The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) Guidelines: An international Delphi consensus study

The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) Guidelines: An international Delphi consensus study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) Guidelines: An international Delphi consensus study Chloé Pronovost-Morgan, Kyle Greenway, Leor Roseman This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5428217/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 03 Jun, 2025 Read the published version in Nature Medicine → Version 1 posted You are reading this latest preprint version Abstract Background Psychedelic substances exhibit complex interactions with the ‘set and setting’ of use, i.e., the internal state of the user and the external environment in which a psychedelic experience takes place. Despite the known importance of these contextual variables, psychedelic research has suffered from methodological weaknesses in reporting extra-pharmacological factors and from a lack of consensus regarding their relative importance. Methods The study aimed to generate consensus-based guidelines for the reporting of settings in psychedelic clinical research, according to a diverse international group of psychedelic researchers, clinicians, and past trial participants. We conducted a large international Delphi consensus study composed of four iterative rounds of quasi-anonymous online surveys and facilitated debates. Findings Eighty-nine experts from 17 countries initially identified hundreds of potentially important psychedelic setting variables. These 770 responses were synthesized into 49 distinct items that were then rated, debated, and refined in subsequent rounds. The process resulted in 30 extra-pharmacological variables reaching pre-defined consensus thresholds: rated “important” or “very important” for reporting by at least 70% of experts. These items compose the Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) guidelines, categorized into: physical environment, dosing session procedure, therapeutic framework and protocol, and subjective experiences. Emergent study findings reveal significant ambiguities in current conceptualizations of set and setting. Interpretation The ReSPCT guidelines and its accompanying explanatory document provide a new standard for the design and documentation of extra-pharmacological variables in psychedelic clinical research. Drug-context interactions warrant further attention to ensure the methodological rigor of psychedelic research. Funding Societal Engagement Seed Fund, Imperial College London. Health sciences/Medical research/Clinical trial design/Randomized controlled trials Biological sciences/Psychology Scientific community and society/Social sciences/Interdisciplinary studies Figures Figure 1 Figure 2 Research in Context Evidence before this study Psychedelic drug effects are strongly influenced by non-pharmacological contextual factors such as physical environments, music, and social interactions. This observation achieved widespread awareness in the mid 20 th century with the popularization of ‘set and setting’, a concept of foundational importance for psychedelic research. Yet, despite widespread recognition of their importance, psychedelic drug-context interactions have thus far been subject to little empirical research throughout the first and ongoing second wave of psychedelic research. There is thus no consensus regarding which non-pharmacological factors most influence psychedelic drug effects at the current time. A significant consequence and perpetuator of this knowledge gap is that psychedelic clinical trial publications rarely describe the non-pharmacological aspects of their interventions with sufficient detail for potential drug-context interactions to be measurable and for overall trial findings to be interpretable. Added value of this study This global Delphi study produced the Reporting of Setting is Psychedelic Clinical Trials (ReSPCT) guidelines over four iterative rounds involving 89 experts with diverse forms of expertise. Its 30 items represent the first international consensus regarding which specific non-pharmacological elements exert the most important influences on psychedelic drug effects, and thus warrant routine reporting. These guidelines achieved a high degree of agreement and perceived quality. In contrast, our study revealed significant heterogeneity in how the concept of set and setting is currently understood. Implication of all the available evidence The ReSPCT guidelines aim to strengthen the design and dissemination of psychedelic clinical research by facilitating reporting practices that are adapted to the unique properties of these drugs. Their 30 items achieved a significantly greater degree of expert consensus than was observed for the concept of ‘set and setting’. Widespread adoption of these guidelines would significantly improve the quality of psychedelic research, much like other reporting guidelines have strengthened the evidence base of other clinical interventions. More research is needed to better characterize and conceptualize the complex ways that pharmacological drug effects and contextual factors interact. Introduction A guiding axiom of the psychedelic paradigm is that these drugs’ pharmacological effects interact with extra-pharmacological variables in complex ways to produce their powerful effects on consciousness. 1, 2 Extra-pharmacological contexts, typically dichotomized as ‘(mind)set and setting’ 3 , can promote drug effects that range from psychotic-like to mystical-like, from the same psychedelic drug at the same dose. 3 Psychedelic drugs are currently subject to intensive study as potential psychiatric treatments. 4, 5 Despite the critical influence of extra-pharmacological factors on these treatments, there is little known about their relative importance, 6, 7 their scope 8 or the temporality of their effects. 9 These major knowledge gaps are perpetuated by inconsistent reporting practices. A recent systematic review of 33 clinical psychedelic studies found that many trials failed to report basic aspects of their contexts, including study locations and physical environments. 10 Such omissions limit the transparency and validity of psychedelic research; 10-12 if psychedelic drug effects are indeed the product of drug-context interactions, methodologically rigorous research requires clear and reliable reporting of contextual variables. 13 The primary aim of this study was to develop guidelines for reporting extra-pharmacological variables in psychedelic clinical trials, initially focused on settings, as has been done for other complex health interventions. 14-16 We aimed to generate guidelines that were parsimonious, straightforward to implement, and reflective of diverse perspectives. To achieve this objective, our study employed the Delphi method, an evidence-based approach to deriving expert consensus on complex topics through iterative surveys. 17 This method was selected for its capacity to integrate diverse forms of academic and experiential knowledge, 18 to facilitate discourse across vast geographical regions, 19 and to enable the productive exchange of knowledge across power differentials and hierarchies by preserving anonymity. 20 To guide future research, the study also aimed to evaluate how set and setting is currently conceptualized in the field. Methods The definition of ‘psychedelics’ varies but is herein broadly defined to include the classical serotonergic psychedelics such as psilocybin, lysergic acid diethylamide (LSD) and dimethyltryptamine (DMT), 21 ‘atypical’ psychedelics like ibogaine and salvinorin, and other acutely psychoactive drugs employed as adjuncts to psychotherapy, such as 3,4-Methylenedioxymethamphetamine (MDMA) and ketamine. 22 This project was designed and implemented according to the Conducting and Reporting Delphi Studies (CREDES) standards (appendix 1, p 3), 23 in addition to other Delphi-specific guidelines available in the literature. 18, 24-26 The study consisted of four sequential rounds of surveys, administered electronically in English using the digital platform Qualtrics, from April to August 2023. The first round consisted of an open-ended question, while subsequent rounds solicited quantitative and qualitative expert feedback on the results of previous rounds. Free-text comments were solicited in each round. Consensus, our primary outcome, was defined a priori as a variable (or ‘item’) being rated as “important” or “very important” for inclusion in reporting guidelines by at least 70% of experts, on a 7-point Likert scale. The 70% threshold was selected as a reasonable intermediate between cut-offs employed in similar Delphi studies, 27 which can range between 51% to 97%. 28 Summary statistics and qualitative analyses were conducted using Microsoft Excel, and plots were generated in both R and Excel (RStudio Version 2021·09·0+351). Expert panel ‘Experts’ were defined as people “having, involving, or displaying special skill or knowledge derived from training or lived experience”. 29 Experts were recruited among psychedelic clinicians, psychedelic researchers, and former psychedelic clinical trial participants with significant knowledge or experience in at least one of the following related areas: psychopharmacology, neuroimaging, psychedelic-assisted therapy, clinical trial design, and/or harm reduction. Clinicians and researchers were identified through searches of the academic literature, conference websites, psychedelic-related institutes or organizations, and the authors’ academic networks. Snowball sampling was also used after initial invitations were sent. 30 Expertise was validated based on academic and professional qualifications, years of relevant experience, and contributions to the field. Past trial participants were primarily recruited in collaboration with the Psychedelic Participant Advocacy Network (PsyPAN), a non-profit organization based in the UK. Expert panel diversity was established based on self-reported sociodemographic characteristics and professional affiliations. Although there is no standard sample size for Delphi studies, most include up to 25 participants, 28 and guidelines recommend at least 15 to 20 experts in any given subgroup for statistical purposes. 31 Accordingly, we aimed to recruit groups of 20 researchers, clinicians, and past trial participants, for a total of 60 experts by Round Four. Taking into account attrition, we sought enrollment of 90 experts for Round One. 32 All experts were recruited by email invitation, with a maximum of two reminders sent for each round. No new experts were sought once Round One was completed (May 2023). All participating experts were given the option to contribute as co-authors or be acknowledged in future publications, and former trial participants were additionally renumerated at a rate of 20GBP per completed survey, based on consultation with PsyPAN. This renumeration was supported with funding from the Imperial College London Societal Engagement Seed Fund, which supports patient and public involvement in research. Ethics Ethical approval for this study was granted by the Imperial College Research Ethics Committee (reference number 6568054). All study participants provided online written consent at the beginning of the first survey. During data collection, participants were quasi-anonymous, i.e., anonymous to other experts but identifiable to the study team. 26 After data collection, personal identifiers were replaced with unique participant identification numbers, with the identifying key encrypted and stored separately. Delphi Rounds Round One The first survey underwent pilot acceptability and fidelity testing with six independent experts, including the two co-founders of PsyPAN. In Round One, all experts were asked to list up to ten setting variables they deemed most important for reporting in psychedelic clinical trials, with the option to provide their rationale for each. The lead author (CPM) first coded all free-text responses in a non-hierarchical manner. Subsequently, the three lead authors collaboratively grouped these codes into broader themes and iteratively refined them to improve clarity and reduce redundancy. This process yielded a preliminary list of distinct items, organized into preliminary sections, with item descriptions summarizing the details and rationales provided by experts. Round Two In Round Two, experts were provided with the list of items and descriptions generated in Round One. For each item, experts were asked to rate the importance of its inclusion in reporting guidelines, coherence – i.e., the clarity of its formulation and description – and to optionally provide additional feedback. Importance ratings were analyzed according to the consensus threshold, both for the entire group and within predefined subgroups of experts according to gender, ethnicity, primary type of expertise, field of expertise, and prior clinical trial experience (appendix 1, p 4). Subgroup analyses are not universal in Delphi studies, 31 but were conducted to identify minority opinions that may otherwise have been overlooked. Items that reached consensus in the entire group or in any subgroup then underwent quality analyses based on coherence, uniqueness, and implementability. Coherence was based on experts responding “yes”, “no” or “unsure” to the prompt “I think this item is coherent/logical”. Uniqueness and implementability were established based on solicited free-text feedback. Items with less than 90% coherence ratings were modified according to expert feedback; items lacking uniqueness were combined with other overlapping items; items identified as having potential implementability issues were flagged for reconsideration. Round Three In Round Three, experts were asked to re-evaluate the items that had reached consensus but had issues with coherence, uniqueness, and/or implementability. For items modified to address coherence issues, experts re-rated the modified item’s importance and coherence. For items combined to reduce excessive overlap, experts indicated whether they agreed or disagreed with the proposed combinations. For items with identified implementability issues, experts voted whether to keep them in the core guidelines, move them to a separate optional subsection, or remove them altogether. Experts were also asked to debate items that reached consensus in at least one subgroup but not across the full sample. They were presented with each debated item’s importance scores for the entire group and for the subgroup(s) in which the item reached consensus, alongside representative quotes spanning the divergent opinions. They then re-rated the debated item’s importance based on this additional information. Lastly, experts were presented with a table of items that did not reach consensus in any subgroup and invited to voice any final opposition to their rejection from the guidelines. Round Four In Round Four, experts were asked to provide feedback on the preliminary reporting guidelines developed over the previous three rounds, and to rate the perceived quality of the study process. Additionally, based on emergent findings of the previous rounds, experts were asked to rate the conceptual overlap, separability, and temporal boundaries of set and setting, and to report whether their understanding of this concept had evolved throughout the study. Quantitative feedback was solicited using various five-point Likert scales and qualitative feedback was collected via free-text responses. Results Study Process and Round Results Recruitment and Study Flow Personalized email invitations to participate were initially sent to 149 experts, followed by an additional 34 experts identified by snowball recruitment. A total of 89 experts (48·6%) consented to participate and all fully completed the first round. Thereafter, 73 experts completed Round 2, 68 experts completed Round 3, and 62 experts completed Round 4, yielding a 30% attrition rate (Figure 1). Demographics The demographic and professional characteristics of the experts who completed the first and final rounds of this study are presented in Table 1, and affiliations in appendix 1, p 5. (Table 1) (Figure 1) Round One The Round One (N = 89) prompt regarding the most important setting variables yielded 770 free-text responses and rationales, which often related to trial participants’ senses of safety and comfort under the influence of psychedelic drugs. These responses were then coded and grouped into a list of 49 unique items (appendix 1, pp 5-8). Each item had been independently suggested by at least two experts, with four items mentioned by at least half of respondents: music and sound (n = 74); objects, decorations, and artwork (n = 55); number of people present (n = 52); and access to nature (n = 46). Round Two In Round Two (N = 73), 33 of the 49 items (67%) from Round One reached whole-group consensus thresholds. One of these, pertaining to aspects of the study protocol, was eliminated based on expert feedback that it is already subject to standard reporting practices in clinical trials, and 15 others were flagged for modification to address issues with coherence, uniqueness, and/or implementability. At this stage, according to the study’s original aims, items that were identified as being largely subjective – i.e., pertaining more to set than to setting – were flagged for implementability issues. Of the 16 items not reaching whole-group consensus, twelve met the consensus threshold in one or more subgroups. Among them, one item was rejected for having a low coherence rating, and another was rejected because of potential privacy concerns for research study personnel. Two items were merged into items that had already reached whole-group consensus, and two other items were combined into a single item to address issues with overlap. The subgroup analyses thus yielded seven items to be debated in Round Three. Overall, during Round Two, 17 items were accepted as written, seven items were rejected, and 27 items were combined into 18 based on whole- and/or subgroup feedback. Round Three In Round Three (N = 68), all newly modified items met the 90% coherence threshold, and the proposed combinations of seven items into three new items surpassed 90% acceptance. Re-ratings of the seven debated items, which had previously only reached subgroup consensus (appendix 1, pp 9-12), resulted in two items reaching whole group consensus and thus being incorporated in the final guidelines (Table 2). Experts were also asked to vote regarding the potential inclusion of the five items collectively identified as referring more to set than to setting due to their subjectivity. Despite the study’s initial focus on setting variables, only 15% of experts voted to exclude these items from the guidelines. Rather, experts supported keeping these items as a standard component of the guidelines (46%) or as an optional subsection pertaining to ‘Participant Experience’ (39%). Based on these responses, these five items examining subjective experiences were included in the final section of the guidelines (Table 3). (Table 2) Overall, Round Three resulted in 13 additional items meeting criteria for acceptance. Added to the 17 accepted items from Round Two, this produced the 30-item Preliminary guidelines for reporting setting in psychedelic clinical trials , reported in appendix 1 with an overview of each items’ progression from Round One to Round Four. Round Four Results from the final round (N = 62) are presented in full in appendix 1. At least 95% of experts reported being satisfied or very satisfied with the preliminary guidelines, and either agreed or strongly agreed that they reflect what is important for reporting in psychedelic clinical trials. Seventy-four percent of experts said they would “definitely” use the guidelines and 25% said they would “consider it”; only one (2%) expert reported they would not. Regarding the study methodology and process, at least 95% of experts rated the survey instructions as clear, the study structure as generally satisfactory, and both deadlines and time commitments as reasonable. Similarly, at least 95% evaluated the study as successful in identifying areas of agreement and disagreement, allowing opinions to be comfortably expressed, and ensuring that diverse voices had been adequately heard. Finally, 68% percent of experts reported that their conceptualization of setting had changed as a result of the study process, mostly in terms of the granularity, scope, and depth with which they considered setting-related variables. The Reporting of Setting in Psychedelic Clinical Trials Guidelines The final Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) 2024 guidelines are presented in Table 3 (fillable format in appendix 2). They were collaboratively refined from the preliminary guidelines by the study leads and experts. The guidelines are accompanied by a comprehensive explanatory document (appendix 3), also produced collaboratively, which provides detailed descriptions of each item, suggested reporting prompts, supporting expert responses and a brief summary of the literature on the 30 ReSPCT items. The ReSPCT guidelines are composed of 30 items divided into four sections. The first section describes the physical and sensory environments to which participants are exposed during a dosing session, such as the study location, decorations, and sensory reduction devices available to participants. The second section pertains to the dosing procedure, including the people present, music provided, and interventions performed. The third section regards the trial’s broader therapeutic framework and protocol, including preparatory and integration activities, 1 and study personnel qualifications. The final section explores key aspects of participants’ subjective experiences, including evaluations of therapeutic alliances, comfort, and both physical and psychological safety. (Table 3) The Conceptualization of Set and Setting As detailed above, an emergent finding of the study’s first three rounds was a lack of clarity and consensus regarding the conceptual boundaries between ‘set’ and ‘setting’. Additional questions were thus posed to experts in Round Four to explore perspectives on this influential concept (Figure 2). When asked to rate their agreement with the statement that set and setting can be studied separately, almost equal proportions agreed/strongly agreed (37%) as disagreed/strongly disagreed (42%). Experts were also asked to estimate the conceptual overlap between set and setting, from 0% to 100%. Responses again ranged widely, with nearly equal proportions of experts estimating conceptual overlap as 20-40%, 40-60% or 60-80%, yielding an average overlap rating of 49%. Additionally, experts were asked to define the temporal boundaries of setting across the standard phases of psychedelic clinical trials. Sixty-eight percent agreed that setting spans from the start of a clinical trial’s recruitment to the end of its follow-up. Only 16% considered setting as limited to the trial’s treatment phase – generally entailing preparation, dosing, and integration subphases 1 – and 10% considered setting to be confined to the actual dosing session. (Figure 2) Discussion The ReSPCT guidelines The 30-item ReSPCT guidelines provide a new standard for the reporting of extra-pharmacological variables in psychedelic clinical trials, derived from an international Delphi-consensus study of experts from 17 different countries and 50 different institutions. The contributing clinicians, researchers, and past trial participants were selected to represent diverse forms of knowledge and perspectives, which were exchanged and debated throughout the iterative Delphi process. The final items span the physical environment of dosing sessions to important aspects of participants’ experiences of psychedelic clinical trial settings. The items of the ReSPCT guidelines are intended to be reported in the texts or supplements of future studies alongside a completed checklist (appendix 2). This practice aims to strengthen the design and documentation of clinical research on psychedelic drugs, and thereby improve the transparency, reproducibility, and validity of this rapidly evolving field. 12, 33 Adoption of these guidelines may also facilitate data comparison and aggregation across different groups and institutions, 34 and inform future dismantling and therapeutic studies 6 . Indeed, such issues recently prompted the US Food and Drug Administration to describe psychedelic therapies as a ‘black box’ 35 and contributed to their recent rejection of MDMA-assisted therapy as a treatment for post-traumatic stress disorder. 36 These guidelines were designed specifically for psychedelic clinical trials but may be adapted to other clinical and research contexts. For instance, they may be valuable in research involving other acutely psychoactive substance, given that potent drug-context interactions have been found with multiple non-psychedelic substances – including alcohol, antidepressants, and opiates. 11 Additionally, the guidelines may facilitate more observational or pragmatic forms for psychedelic research. 37 The challenges of blinding in psychedelic research may prove to be insurmontable; 38 the ReSPCT guidelines could therefore support pragmatic study designs that prioritize the careful curation and systematic reporting of contextual variables over efforts to mask or minimize their influences. 37, 39 Conceptual challenges and heterogenous views on set and setting The study revealed diverse initial views regarding the relative importance of various components of settings. Some of the final items, such as music and access to nature, were independently suggested by most experts in the first round and retained high agreement throughout the study. Others, such as narrative framings, and the positioning of people in treatment rooms, were mentioned by few but rapidly reached consensus thresholds thereafter. Two items that feature in the ReSPCT guidelines initially failed to reach whole-group consensus but were rescued by the debate process. For instance, in Round Two, ‘Cultural competence and safety’ (Item 25) reached consensus only in two subgroups. Cultural competence refers to a study team’s ability to care for participants with diverse values, beliefs, and behaviors, 40 while cultural safety focuses on increasing health equity by encouraging healthcare professionals to examine power imbalances in patient-provider interactions. 41 In Round Three, multiple experts supported this item’s importance, citing concerns regarding power imbalances and a lack of diversity in psychedelic clinical and research contexts. 42-45 As a result, the item’s whole-group rating increased from 50% to 73%, leading to its inclusion in the final guidelines. The study process also identified challenges associated with how set and setting is currently conceptualized. Despite the study’s original focus on setting variables, early results and a subsequent vote led to the inclusion of five items that align more closely with the concept of (mind)set in the final guidelines’ last section. In contrast to the consensus achieved regarding the relative importance of specific extra-pharmacological variables, expert views on the concept of set and setting itself remained highly heterogenous. For instance, in the final round, expert views were evenly divided regarding the perceived overlap and the separability of set and setting variables. The discrepant understandings of ‘set and setting’ amongst experts likely contributes to inconsistent reporting practices in psychedelic clinical trials. The ReSPCT guidelines aim to bypass this confusion with an explicit list of 30 key extrapharmacological factors that are understood as interrelated, rather than as dichotomous. I.e., a study’s environment and therapeutic approach may interactively shape participant experiences, and those experiences may influence how extra-pharmacological factors are perceived or even adapted. The guidelines thus prioritize specificity over simplicity in the aim of improving psychedelic clinical research practices. Further study is needed to evaluate if the utility of ‘set and setting’ outweighs its conceptual confusion in other contexts. Limitations Despite the study’s strengths, several limitations must be acknowledged. First, the Delphi process was entirely survey-based, which may have reduced the spontaneity and depth of dialogue that can occur in face-to-face interactions. Secondly, the study’s sample of experts did not represent the full diversity of perspectives on these drugs. For instance, the study’s focus on clinical trials excluded broader, non-clinical perspectives on variables that shape psychedelic experiences. It also resulted in most experts being relatively young and originating from Western countries, where psychedelic clinical research is currently most highly concentrated. Relatedly, the study’s definition of expertise reproduced known issues of the psychedelic field, 43, 44 namely the current lack of racial diversity amongst psychedelic researchers and trial participants. This limitation was only partially overcome through the study’s subgroup process, given that 75-80% of the sample was White. Finally, expertise does not necessarily equate to truth, and opinions of current psychedelic experts must be situated in the current historical moment and body of knowledge. Further empirical research is needed to evaluate the actual importance of the variables that have been included in, or excluded from, the ReSPCT guidelines, and to discern those most relevant to clinical outcomes. Conclusion The ReSPCT guidelines aim to advance the study of psychedelic drugs and therapies just as reporting guidelines have improved the transparency and interpretability of other complex clinical interventions. 15, 16, 46 Its 30 items reflect a necessary, if preliminary, expert consensus regarding the most important contextual factors to report in studies of psychedelic drugs. The accompanying explanatory document serves to facilitate reporting and guide future research by synthesizing the current literature regarding contextual influences on psychedelic drug effects. Routine utilization of these guidelines could significantly improve the rigor of psychedelic research, mitigate the ambiguities of current understandings of set and setting, and potentially facilitate the future clinical implementation of these promising therapies in safe, transparent, and effective ways. Declarations Acknowledgments We would like to acknowledge the contributions of the following individuals to the Delphi process: Dr. Friedericke Meckel, Dr. Simon Amar, Dr. Willoughby Britton, and Mr. Thomas Hartle. Mr Hartle, who recently passed away, was the first Canadian to receive psilocybin for end-of-life distress associated with a terminal cancer diagnosis. He was a strong advocate for psychedelic research and a valued contributor to this study. Data sharing statement Deidentified data collected as part of the study, as well as additional study materials such as study surveys, will be made available upon reasonable requests for purposes deemed to be scientifically valid by the study authors. Requests for data or additional study materials can be made to the corresponding author. Sharing of data will be contingent on an executed data transfer agreement. Declarations of interest The authors have no conflicts of interest to declare. 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British Journal of Occupational Therapy. 1998;61(4):153–6. Aday JS, Heifets BD, Pratscher SD, Bradley E, Rosen R, Woolley JD. Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials. Psychopharmacology (Berl). 2022;239(6):1989–2010. Butler-Struben HM, Kentner AC, Trainor BC. What's wrong with my experiment?: The impact of hidden variables on neuropsychopharmacology research. Neuropsychopharmacology. 2022;47(7):1285–91. Marks M. Psychedelic Therapy Scrutinized by FDA Advisory Committee? JAMA. 2024. Reardon S. FDA rejects ecstasy as a therapy: what's next for psychedelics? Nature. 2024. Carhart-Harris RL, Wagner AC, Agrawal M, Kettner H, Rosenbaum JF, Gazzaley A, et al. Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine? J Psychopharmacol. 2022;36(1):6–11. Muthukumaraswamy SD, Forsyth A, Lumley T. Blinding and expectancy confounds in psychedelic randomized controlled trials. Expert review of clinical pharmacology. 2021;14(9):1133–52. Brives C, Le Marcis F, Sanabria E. What's in a Context? Tenses and Tensions in Evidence-Based Medicine. Medical anthropology. 2016;35(5):369–76. Betancourt JR, Green AR, Carrillo JE, Owusu Ananeh-Firempong I. Defining cultural competence: a practical framework for addressing racial/ethnic disparities in health and health care. Public health reports. 2003. Lokugamage AU, Rix EL, Fleming T, Khetan T, Meredith A, Hastie CR. Translating cultural safety to the UK. Journal of medical ethics. 2023;49(4):244–51. Thrul J, Garcia-Romeu A. Whitewashing psychedelics: racial equity in the emerging field of psychedelic-assisted mental health research and treatment. Drugs: Education, Prevention and Policy. 2021;28(3):211–4. George JR, Michaels TI, Sevelius J, Williams MT. The psychedelic renaissance and the limitations of a White-dominant medical framework: A call for indigenous and ethnic minority inclusion. Journal of Psychedelic Studies. 2020;4(1):4–15. Michaels TI, Purdon J, Collins A, Williams MT. Inclusion of people of color in psychedelic-assisted psychotherapy: a review of the literature. BMC Psychiatry. 2018;18(1):245. Williams MT, Labate BC. Diversity, equity, and access in psychedelic medicine. Journal of Psychedelic Studies. 2020;4(1):1–3. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Bmj. 2008;337. Tables Table 1 Expert participants’ sociodemographic and professional characteristics in the first and final study rounds. Expert demographics Round One (N = 89) Round Four (N = 62) Category Count (Percentage) Count (Percentage) Gender identity Female 36 (40·4%) 26 (41·9%) Male 48 (53·9%) 32 (51·6%) Non-binary 4 (4·5%) 3 (4·8%) Age 25–34 19 (21·3%) 11 (17·7%) 35–44 33 (37·1%) 25 (40·3%) 45–54 21 (23·6%) 13 (21·0%) 55–64 8 (9·0%) 7 (11·3%) 65+ 8 (9·0%) 6 (9·7%) Ethnicity Asian (Indian, Pakistani, Bangladeshi, Chinese, any other Asian background) 3 (3·4%) 2 (3·2%) Black / African / Caribbean 1 (1·1%) 0 (0·0%) Hispanic / Latino 1 (1·1%) 1 (1·6%) Indigenous 7 (7·9%) 4 (6·5%) Middle Eastern or North African 3 (3·4%) 1 (1·6%) Mediterranean 2 (2·2%) 1 (1·6%) Mixed two or more ethnic groups 5 (5·6%) 2 (3·2%) White 66 (74·2%) 50 (80·6%) Prefer not to say 1 (1·1%) 1 (1·6%) Nationality United States of America 22 (24·7%) 16 (25·8%) United Kingdom of Great Britain and Northern Ireland 17 (19·1%) 14 (22·6%) Canada 17 (19·1%) 12 (19·4%) Australia 5 (5·6%) 3 (4·8%) Switzerland 5 (5·6%) 4 (6·5%) Netherlands 4 (4·5%) 3 (4·8%) Brazil 3 (3·4%) 3 (4·8%) Germany 3 (3·4%) 0 (0·0%) Spain 3 (3·4%) 1 (1·6%) Denmark 2 (2·2%) 0 (0·0%) Israel 2 (2·2%) 1 (1·6%) Other: Chile, France, Greece, Hungary, Mexico, South Africa 6 (6·7%) 5 (8·1%) Education level Bachelor's Degree 8 (9·1%) 7 (11·3%) Master's Degree 18 (20·5%) 11 (17·7%) Doctorate or Professional Degree 59 (67·0%) 40 (64·5%) Vocational school 3 (3·4%) 3 (4·8%) Expert type* Researcher 64 (71·9%) 42 (67·7%) Clinician 39 (43·8%) 24 (38·7%) Participant 19 (21·3%) 16 (25·8%) Field of expertise* Science 62 (69·7%) 37 (59·7%) Psychology 42 (47·2%) 28 (45·2%) Social science (other than psychology) 44 (49·4%) 31 (50·0%) Plant medicine 4 (4·5%) 2 (3·2%) N/A 10 (11·2%) 9 (14·5%) Years working in psychedelic field 1 to 5 26 (29·2%) 20 (32·3%) 5 to 10 19 (21·3%) 11 (17·7%) 10 to 15 12 (13·5%) 8 (12·9%) 15+ 32 (36·0%) 23 (37·1%) Self-reported form of psychedelic expertise* Lived experience 50 (56·2%) 41 (66·1%) Set and setting 46 (51·7%) 31 (50·0%) Psychedelic therapy in a clinical context 45 (50·6%) 33 (53·2%) Conducting clinical trials 30 (33·7%) 21 (33·9%) Psychedelic therapy in non-clinical contexts 27 (30·3%) 19 (30.6%) Psychedelic psychopharmacology 23 (25·8%) 15 (24·2%) Drug policy and/or harm reduction 21 (23·6%) 17 (27·4%) Psychedelic neuroimaging 14 (15·7%) 8 (12·9%) Other: physiotherapy, data science, ancestral medicine, design, literature, arts and aesthetics, spiritual care, nursing, social work. 13 (14·6%) 7 (11·3%) Self-reported expertise regarding specific psychedelic drugs* Psilocybin 80 (89·9%) 54 (87·1%) MDMA 52 (58·4%) 37 (59·7%) LSD 48 (53·9%) 33 (53·2%) Ayahuasca 40 (44·9%) 29 (46·8%) Ketamine 38 (42·7%) 29 (46·8%) DMT 33 (37·1%) 23 (37·1%) Mescaline 26 (29·2%) 20 (32·3%) 5-MeO-DMT 18 (20·2%) 12 (19·4%) Ibogaine 5 (5·6%) 5 (8·1%) Other: cannabis, tobacco, Salvinorin A, 3,4-Methylenedioxyamphetamine (MDA), N,N -Dipropyltryptamine (DBP), Nitrous oxide. 8 (9·0%) 5 (8·1%) *Percentages do not amount to 100% as experts may have endorsed more than one form of expertise. Table 2 Items debated in Round 3 due to reaching consensus threshold in one or more subgroups but not the overall group. *Cultural competence and cultural safety were originally two separate items that were merged as per expert feedback. Debated item Ratings in overall group Ratings in groups in which item met consensus threshold Reasons provided for (and against) item’s inclusion in reporting guidelines Items that ultimately achieved consensus Bathroom facilities 60% BIPOC or mixed ethnicity: 14/18 (78%) Past trial participants: 16/20 (80%) Bathroom accessibility and privacy may influence the experiences of participants in vulnerable states induced by psychedelic drugs. Facilitators’ cultural competence and safety* 52% competence 47% safety BIPOC or mixed ethnicity: 14/18 (78%) competence 13/18 (72%) safety Plant medicine: 4/4 (100%) both Non-binary: 3/4 (75%) safety Study facilitators’ capacity to provide culturally competent and safe care may impact how participants from diverse backgrounds experience the study, and have important ramifications on the broader field’s diversity, equity, and inclusivity. Items that ultimately failed to achieve consensus Odours, scents, smells 58% Past trial participants: 15/20 (75%) Plant medicine: 4/4 (100%) The capacity for olfactory stimuli to invoke memories and/or influence emotions may be heightened under the effects of psychedelic drugs. Temperature 58% BIPOC or mixed ethnicity: 15/18 (83%) Past trial participants: 14/20 (70%) Social sciences: 19/26 (73%) Plant medicine: 4/4 (100%) Temperature may influence participant comfort and sense of control over their environment, and thereby shape their psychedelic experience. Facilitators demographics and cultural backgrounds 60% Non-binary: 3/4 (75%) BIPOC or mixed ethnicity: 14/18 (78%) Clinicians: 22/31 (71%) No clin. trial experience: 19/25 (76%) Study facilitators’ backgrounds and beliefs may directly or indirectly shape psychedelic experiences through interactions with participants. However, collecting and reporting such information may raise privacy concerns. Sociocultural context 56% Non-binary: 3/4 (75%) BIPOC or mixed ethnicity: 15/18 (83%) Past trial participants: 14/20 (70%) Plant medicine: 4/4 (100%) Psychedelic experiences may be influenced by both current and past societal factors, including media coverage, legal statuses, and mainstream perceptions of psychedelic drugs. However, such influences may be too broad and complex to be accurately captured and reported. Social determinants of health 68% Male: 27/38 (71%) Non-binary: 3/4 (75%) BIPOC or mixed ethnicity: 16/18 (89%) Clinicians: 23/31 (74%) Social sciences: 22/26 (85%) Plant medicine: 4/4 (100%) No clin. trial experience: 19/25 (76%) Social determinants of health exert important influences on mental and physical wellbeing, and likely influence psychedelic clinical trial outcomes. However, social determinants are defined in diverse ways, and they may be challenging to accurately report due to their breadth and complexity. Table 3 The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) 2024 guidelines. Caption : The ReSPCT guidelines serve as a reporting tool for settings in clinical trials with psychedelics. Each item should be reported in the main text or supplement of the resultant publication(s), the location of which should be indicated in the accompanying checklist (appendix 2). The supporting explanatory document (appendix 3) provides details and further guidance, including relevant research and suggested reporting prompts for each item. Item Item Number Item details Physical environment Location 1 Location of the trial, and whether indoors/outdoors and urban/rural/suburban. Ambiance 2 Room ambiance curated by the study team. Access to nature 3 Sources of nature or natural elements that are physically or visually accessible to participants. Objects and decorations 4 Objects and decorations in the room. Lighting 5 Room lighting and adjustability. Sensory reduction 6 Sensory reduction used, such as headphones and eyeshades. Bathroom facilities 7 Level of bathroom accessibility, privacy, and safety. Dosing session procedure Number and roles of people present 8 Number and roles of people present, including participants, study staff and informal support. Positioning 9 Relative position of people in the room, and what participants were positioned on (e.g., bed, mat, couch). Focus and main activities 10 Focus (internal or external) and main activities of the dosing session. Music or soundscapes 11 Music or soundscapes that accompanied the dosing experience. Interpersonal interventions 12 Verbal or physical interpersonal interventions used throughout the session, and how consent was obtained. Participant autonomy, control, and agency 13 Level of participant control and agency over activities and environment of the dosing session. Dosing regimen 14 Dosing regimen, including drug dose(s), frequency, route of administration and length of the dosing session. Medical and experimental procedures or assessments 15 Medical and experimental procedures or assessments performed during the dosing session. Pre- and post-dosing protocol 16 Activities that took place immediately prior to- or post-dosing, including participant arrival and release conditions. Potential disturbances or interruptions 17 Disturbances or interruptions that may have impacted the quality of the dosing session. Therapeutic framework and protocol Therapeutic or guiding approach 18 Therapeutic or guiding approach used throughout the study, if any, with the accompanying manual or protocol. Narrative framing 19 Framing of the trial intervention by the study team, including the short- and long-term drug effects. Number of sessions 20 Number and length of preparation, dosing, and integration sessions. Preparation protocol 21 Activities performed during the preparation sessions. Integration protocol 22 Activities performed during the integration sessions. Additional support or follow-up 23 Formal or informal support or follow-up offered to participants after the end of the trial, including in the case of adverse events. Study personnel qualifications 24 The credentials, training, and expertise of personnel providing the study intervention or care. Cultural competence and safety 25 Study team's level of cultural competence and efforts towards cultural safety. Subjective experiences Therapeutic alliance 26 Therapeutic alliance between participants and facilitators throughout the intervention. Trust 27 Participant's level of trust throughout the intervention. Physical comfort 28 Participant's level of physical comfort during the dosing session. Physical safety 29 Participant's sense of physical safety during the dosing session. Psychological and cultural safety 30 Participant's sense of psychological and cultural safety with the people present during the dosing session. Full Author List The full author list can be found in the supplemental file "Title_page.docx". Additional Declarations There is NO Competing Interest. Supplementary Files Titlepage.docx Appendix1tables18.docx Appendix2ReSPCTguidelineschecklistreportingtable.docx Appendix3ExplanatorydocumentforReSPCTguidelines.docx Cite Share Download PDF Status: Published Journal Publication published 03 Jun, 2025 Read the published version in Nature Medicine → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5428217","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":376821459,"identity":"ddbda11c-d77e-4592-9691-c0bb41b130ba","order_by":0,"name":"Chloé Pronovost-Morgan","email":"data:image/png;base64,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","orcid":"","institution":"McGill Univeristy","correspondingAuthor":true,"prefix":"","firstName":"Chloé","middleName":"","lastName":"Pronovost-Morgan","suffix":""},{"id":376821460,"identity":"891f9dfa-dc27-47d7-8cd2-3485f7f50355","order_by":1,"name":"Kyle Greenway","email":"","orcid":"","institution":"McGill","correspondingAuthor":false,"prefix":"","firstName":"Kyle","middleName":"","lastName":"Greenway","suffix":""},{"id":376821461,"identity":"828e1832-f2d7-41e9-8120-76a89ed5a535","order_by":2,"name":"Leor Roseman","email":"","orcid":"","institution":"University of Exeter","correspondingAuthor":false,"prefix":"","firstName":"Leor","middleName":"","lastName":"Roseman","suffix":""}],"badges":[],"createdAt":"2024-11-11 02:30:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5428217/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5428217/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41591-025-03685-9","type":"published","date":"2025-06-03T04:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":69251479,"identity":"0a59ec96-c4fc-46d9-af0b-07a658a74ed3","added_by":"auto","created_at":"2024-11-18 11:47:58","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":314472,"visible":true,"origin":"","legend":"\u003cp\u003eFlow diagram for study participants and items.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCaption\u003c/strong\u003e: Diagram exhibiting the Delphi study flow, from recruitment to final round. The diagram includes the number of participating experts per round, and the item’s progression from inception to being accepted, debated, improved, or rejected.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5428217/v1/aa6206644b0a027bd58c24da.png"},{"id":69251478,"identity":"bac64db8-2de3-42ab-869e-ee6656db3f21","added_by":"auto","created_at":"2024-11-18 11:47:58","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":129669,"visible":true,"origin":"","legend":"\u003cp\u003eExpert responses regarding the separability and conceptual overlap of set and setting factors, and temporal span of setting in psychedelic clinical trials.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCaption\u003c/strong\u003e: Panel A. Experts rated their level of agreement with the statement “set and setting can be studied separately” on a 5-point Likert scale. Panel B. Experts rated the conceptual overlap between set and setting on a scale from 0 (no overlap) to 100 (complete overlap). Panel C. Experts indicated the span of setting in the context of a clinical trial according to the following options: from the start to end of the dosing session; throughout the treatment phase (preparation, dosing, and integration); from recruitment to follow-up; or other.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5428217/v1/974c447760d7644782c24161.png"},{"id":83887721,"identity":"65bc7cb9-7d46-444f-97ba-9720c5fc4b80","added_by":"auto","created_at":"2025-06-04 07:09:03","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1724539,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5428217/v1/4fca6cfe-5dfc-4d13-83f8-e00831e0d8b6.pdf"},{"id":69847557,"identity":"46d86749-8f10-48f7-a89f-c55399d3bdb5","added_by":"auto","created_at":"2024-11-25 20:41:59","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":41248,"visible":true,"origin":"","legend":"","description":"","filename":"Titlepage.docx","url":"https://assets-eu.researchsquare.com/files/rs-5428217/v1/c07b7af7ccc33ba502b6d13e.docx"},{"id":69252762,"identity":"a3435228-d0ce-471a-a96e-dd9a64dd0838","added_by":"auto","created_at":"2024-11-18 11:55:58","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":94108,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix1tables18.docx","url":"https://assets-eu.researchsquare.com/files/rs-5428217/v1/3a1648b18a994cc3ad521243.docx"},{"id":69253138,"identity":"923bfde2-7a13-4957-aeb0-b930f0573c76","added_by":"auto","created_at":"2024-11-18 12:03:58","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":23256,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix2ReSPCTguidelineschecklistreportingtable.docx","url":"https://assets-eu.researchsquare.com/files/rs-5428217/v1/d6ee289ea5df0e9e9e5af413.docx"},{"id":69251482,"identity":"8c220ca8-0b1c-4c2e-b6f4-d0fec8cad00d","added_by":"auto","created_at":"2024-11-18 11:47:58","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":211895,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix3ExplanatorydocumentforReSPCTguidelines.docx","url":"https://assets-eu.researchsquare.com/files/rs-5428217/v1/17922911d8149394b7920378.docx"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e Competing Interest.","formattedTitle":"The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) Guidelines: An international Delphi consensus study","fulltext":[{"header":"Research in Context","content":"\u003cp\u003e\u003cstrong\u003eEvidence before this study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePsychedelic drug effects are strongly influenced by non-pharmacological contextual factors such as physical environments, music, and social interactions. This observation achieved widespread awareness in the mid 20\u003csup\u003eth\u003c/sup\u003e century with the popularization of \u0026lsquo;set and setting\u0026rsquo;, a concept of foundational importance for psychedelic research. Yet, despite widespread recognition of their importance, psychedelic drug-context interactions have thus far been subject to little empirical research throughout the first and ongoing second wave of psychedelic research. There is thus no consensus regarding which non-pharmacological factors most influence psychedelic drug effects at the current time. A significant consequence and perpetuator of this knowledge gap is that psychedelic clinical trial publications rarely describe the non-pharmacological aspects of their interventions with sufficient detail for potential drug-context interactions to be measurable and for overall trial findings to be interpretable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdded value of this study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis global Delphi study produced the Reporting of Setting is Psychedelic Clinical Trials (ReSPCT) guidelines over four iterative rounds involving 89 experts with diverse forms of expertise. Its 30 items represent the first international consensus regarding which specific non-pharmacological elements exert the most important influences on psychedelic drug effects, and thus warrant routine reporting. These guidelines achieved a high degree of agreement and perceived quality. In contrast, our study revealed significant heterogeneity in how the concept of set and setting is currently understood.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplication of all the available evidence\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe ReSPCT guidelines aim to strengthen the design and dissemination of psychedelic clinical research by facilitating reporting practices that are adapted to the unique properties of these drugs. Their 30 items achieved a significantly greater degree of expert consensus than was observed for the concept of \u0026lsquo;set and setting\u0026rsquo;. Widespread adoption of these guidelines would significantly improve the quality of psychedelic research, much like other reporting guidelines have strengthened the evidence base of other clinical interventions. More research is needed to better characterize and conceptualize the complex ways that pharmacological drug effects and contextual factors interact.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eA guiding axiom of the psychedelic paradigm is that these drugs\u0026rsquo; pharmacological effects interact with extra-pharmacological variables in complex ways to produce their powerful effects on consciousness.\u003csup\u003e1, 2\u003c/sup\u003e Extra-pharmacological contexts, typically dichotomized as \u0026lsquo;(mind)set and setting\u0026rsquo;\u003csup\u003e3\u003c/sup\u003e, can promote drug effects that range from psychotic-like to mystical-like, from the same psychedelic drug at the same dose.\u003csup\u003e3\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePsychedelic drugs are currently subject to intensive study as potential psychiatric treatments.\u003csup\u003e4, 5\u003c/sup\u003e Despite the critical influence of extra-pharmacological factors on these treatments, there is little known about their relative importance,\u003csup\u003e6, 7\u003c/sup\u003e their scope\u003csup\u003e8\u003c/sup\u003e or the temporality of their effects.\u003csup\u003e9\u003c/sup\u003e These major knowledge gaps are perpetuated by inconsistent reporting practices. A recent systematic review of 33 clinical psychedelic studies found that many trials failed to report basic aspects of their contexts, including study locations and physical environments.\u003csup\u003e10\u003c/sup\u003e Such omissions limit the transparency and validity of psychedelic research;\u003csup\u003e10-12\u003c/sup\u003e if psychedelic drug effects are indeed the product of drug-context interactions, methodologically rigorous research requires clear and reliable reporting of contextual variables.\u003csup\u003e13\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe primary aim of this study was to develop guidelines for reporting extra-pharmacological variables in psychedelic clinical trials, initially focused on settings, as has been done for other complex health interventions.\u003csup\u003e14-16\u003c/sup\u003e We aimed to generate guidelines that were parsimonious, straightforward to implement, and reflective of diverse perspectives. To achieve this objective, our study employed the Delphi method, an evidence-based approach to deriving expert consensus on complex topics through iterative surveys.\u003csup\u003e17\u003c/sup\u003e This method was selected for its capacity to integrate diverse forms of academic and experiential knowledge,\u003csup\u003e18\u003c/sup\u003e to facilitate discourse across vast geographical regions,\u003csup\u003e19\u003c/sup\u003e and to enable the productive exchange of knowledge across power differentials and hierarchies by preserving anonymity.\u003csup\u003e20\u003c/sup\u003e To guide future research, the study also aimed to evaluate how set and setting is currently conceptualized in the field.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe definition of \u0026lsquo;psychedelics\u0026rsquo; varies but is herein broadly defined to include the classical serotonergic psychedelics such as psilocybin, lysergic acid diethylamide (LSD) and dimethyltryptamine (DMT),\u003csup\u003e21\u003c/sup\u003e \u0026lsquo;atypical\u0026rsquo; psychedelics like ibogaine and salvinorin, and other acutely psychoactive drugs employed as adjuncts to psychotherapy, such as 3,4-Methylenedioxymethamphetamine (MDMA) and ketamine.\u003csup\u003e22\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThis project was designed and implemented according to the Conducting and Reporting Delphi Studies (CREDES) standards (appendix 1, p 3),\u003csup\u003e23\u003c/sup\u003e in addition to other Delphi-specific guidelines available in the literature.\u003csup\u003e18, 24-26\u003c/sup\u003e The study consisted of four sequential rounds of surveys, administered electronically in English using the digital platform Qualtrics, from April to August 2023.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe first round consisted of an open-ended question, while subsequent rounds solicited quantitative and qualitative expert feedback on the results of previous rounds. Free-text comments were solicited in each round. Consensus, our primary outcome, was defined \u003cem\u003ea priori\u003c/em\u003e as a variable (or \u0026lsquo;item\u0026rsquo;) being rated as \u0026ldquo;important\u0026rdquo; or \u0026ldquo;very important\u0026rdquo; for inclusion in reporting guidelines by at least 70% of experts, on a 7-point Likert scale. The 70% threshold was selected as a reasonable intermediate between cut-offs employed in similar Delphi studies,\u003csup\u003e27\u003c/sup\u003e which can range between 51% to 97%.\u003csup\u003e28\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eSummary statistics and qualitative analyses were conducted using Microsoft Excel, and plots were generated in both R and Excel (RStudio Version 2021\u0026middot;09\u0026middot;0+351).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExpert panel\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026lsquo;Experts\u0026rsquo; were defined as people \u0026ldquo;having, involving, or displaying special skill or knowledge derived from training or lived experience\u0026rdquo;.\u003csup\u003e29\u003c/sup\u003e Experts were recruited among psychedelic clinicians, psychedelic researchers, and former psychedelic clinical trial participants with significant knowledge or experience in at least one of the following related areas: psychopharmacology, neuroimaging, psychedelic-assisted therapy, clinical trial design, and/or harm reduction. Clinicians and researchers were identified through searches of the academic literature, conference websites, psychedelic-related institutes or organizations, and the authors\u0026rsquo; academic networks. Snowball sampling was also used after initial invitations were sent.\u003csup\u003e30\u003c/sup\u003e Expertise was validated based on academic and professional qualifications, years of relevant experience, and contributions to the field. Past trial participants were primarily recruited in collaboration with the Psychedelic Participant Advocacy Network (PsyPAN), a non-profit organization based in the UK. Expert panel diversity was established based on self-reported sociodemographic characteristics and professional affiliations.\u003c/p\u003e\n\u003cp\u003eAlthough there is no standard sample size for Delphi studies, most include up to 25 participants,\u003csup\u003e28\u003c/sup\u003e and guidelines recommend at least 15 to 20 experts in any given subgroup for statistical purposes.\u003csup\u003e31\u003c/sup\u003e Accordingly, we aimed to recruit groups of 20 researchers, clinicians, and past trial participants, for a total of 60 experts by Round Four. Taking into account attrition, we sought enrollment of 90 experts for Round One.\u003csup\u003e32\u003c/sup\u003e All experts were recruited by email invitation, with a maximum of two reminders sent for each round. No new experts were sought once Round One was completed (May 2023).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll participating experts were given the option to contribute as co-authors or be acknowledged in future publications, and former trial participants were additionally renumerated at a rate of 20GBP per completed survey, based on consultation with PsyPAN. This renumeration was supported with funding from the Imperial College London Societal Engagement Seed Fund, which supports patient and public involvement in research.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval for this study was granted by the Imperial College Research Ethics Committee (reference number 6568054). All study participants provided online written consent at the beginning of the first survey. During data collection, participants were quasi-anonymous, i.e., anonymous to other experts but identifiable to the study team.\u003csup\u003e26\u003c/sup\u003e After data collection, personal identifiers were replaced with unique participant identification numbers, with the identifying key encrypted and stored separately.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDelphi Rounds\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound One\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe first survey underwent pilot acceptability and fidelity testing with six independent experts, including the two co-founders of PsyPAN. In Round One, all experts were asked to list up to ten setting variables they deemed most important for reporting in psychedelic clinical trials, with the option to provide their rationale for each. The lead author (CPM) first coded all free-text responses in a non-hierarchical manner. Subsequently, the three lead authors collaboratively grouped these codes into broader themes and iteratively refined them to improve clarity and reduce redundancy. This process yielded a preliminary list of distinct items, organized into preliminary sections, with item descriptions summarizing the details and rationales provided by experts.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound Two\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn Round Two, experts were provided with the list of items and descriptions generated in Round One. For each item, experts were asked to rate the \u003cem\u003eimportance\u003c/em\u003e of its inclusion in reporting guidelines, \u003cem\u003ecoherence\u003c/em\u003e \u0026ndash; i.e., the clarity of its formulation and description \u0026ndash; and to optionally provide additional feedback.\u003c/p\u003e\n\u003cp\u003eImportance ratings were analyzed according to the consensus threshold, both for the entire group and within predefined subgroups of experts according to gender, ethnicity, primary type of expertise, field of expertise, and prior clinical trial experience (appendix 1, p 4). Subgroup analyses are not universal in Delphi studies,\u003csup\u003e31\u003c/sup\u003e but were conducted to identify minority opinions that may otherwise have been overlooked.\u003c/p\u003e\n\u003cp\u003eItems that reached consensus in the entire group or in any subgroup then underwent quality analyses based on coherence, uniqueness, and implementability. Coherence was based on experts responding \u0026ldquo;yes\u0026rdquo;, \u0026ldquo;no\u0026rdquo; or \u0026ldquo;unsure\u0026rdquo; to the prompt \u0026ldquo;I think this item is coherent/logical\u0026rdquo;. Uniqueness and implementability were established based on solicited free-text feedback. Items with less than 90% coherence ratings were modified according to expert feedback; items lacking uniqueness were combined with other overlapping items; items identified as having potential implementability issues were flagged for reconsideration.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound Three\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn Round Three, experts were asked to re-evaluate the items that had reached consensus but had issues with coherence, uniqueness, and/or implementability. For items modified to address coherence issues, experts re-rated the modified item\u0026rsquo;s importance and coherence. For items combined to reduce excessive overlap, experts indicated whether they agreed or disagreed with the proposed combinations. For items with identified implementability issues, experts voted whether to keep them in the core guidelines, move them to a separate optional subsection, or remove them altogether.\u003c/p\u003e\n\u003cp\u003eExperts were also asked to debate items that reached consensus in at least one subgroup but not across the full sample. They were presented with each debated item\u0026rsquo;s importance scores for the entire group and for the subgroup(s) in which the item reached consensus, alongside representative quotes spanning the divergent opinions. They then re-rated the debated item\u0026rsquo;s importance based on this additional information.\u003c/p\u003e\n\u003cp\u003eLastly, experts were presented with a table of items that did not reach consensus in any subgroup and invited to voice any final opposition to their rejection from the guidelines.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound Four\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn Round Four, experts were asked to provide feedback on the preliminary reporting guidelines developed over the previous three rounds, and to rate the perceived quality of the study process. Additionally, based on emergent findings of the previous rounds, experts were asked to rate the conceptual overlap, separability, and temporal boundaries of set and setting, and to report whether their understanding of this concept had evolved throughout the study. Quantitative feedback was solicited using various five-point Likert scales and qualitative feedback was collected via free-text responses.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eStudy Process and Round Results\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRecruitment and Study Flow\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePersonalized email invitations to participate were initially sent to 149 experts, followed by an additional 34 experts identified by snowball recruitment. A total of 89 experts (48\u0026middot;6%) consented to participate and all fully completed the first round. Thereafter, 73 experts completed Round 2, 68 experts completed Round 3, and 62 experts completed Round 4, yielding a 30% attrition rate (Figure 1).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDemographics\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe demographic and professional characteristics of the experts who completed the first and final rounds of this study are presented in Table 1, and affiliations in appendix 1, p 5.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e(Table 1)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e(Figure 1)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound One\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe Round One (N = 89) prompt regarding the most important setting variables yielded 770 free-text responses and rationales, which often related to trial participants\u0026rsquo; senses of safety and comfort under the influence of psychedelic drugs. These responses were then coded and grouped into a list of 49 unique items (appendix 1, pp 5-8). Each item had been independently suggested by at least two experts, with four items mentioned by at least half of respondents: music and sound (n = 74); objects, decorations, and artwork (n = 55); number of people present (n = 52); and access to nature (n = 46).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound Two\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn Round Two (N = 73), 33 of the 49 items (67%) from Round One reached whole-group consensus thresholds. One of these, pertaining to aspects of the study protocol, was eliminated based on expert feedback that it is already subject to standard reporting practices in clinical trials, and 15 others were flagged for modification to address issues with coherence, uniqueness, and/or implementability. At this stage, according to the study\u0026rsquo;s original aims, items that were identified as being largely subjective \u0026ndash; i.e., pertaining more to set than to setting \u0026ndash; were flagged for implementability issues.\u003c/p\u003e\n\u003cp\u003eOf the 16 items not reaching whole-group consensus, twelve met the consensus threshold in one or more subgroups. Among them, one item was rejected for having a low coherence rating, and another was rejected because of potential privacy concerns for research study personnel. Two items were merged into items that had already reached whole-group consensus, and two other items were combined into a single item to address issues with overlap. The subgroup analyses thus yielded seven items to be debated in Round Three.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOverall, during Round Two, 17 items were accepted as written, seven items were rejected, and 27 items were combined into 18 based on whole- and/or subgroup feedback.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound Three\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn Round Three (N = 68), all newly modified items met the 90% coherence threshold, and the proposed combinations of seven items into three new items surpassed 90% acceptance. Re-ratings of the seven debated items, which had previously only reached subgroup consensus (appendix 1, pp 9-12), resulted in two items reaching whole group consensus and thus being incorporated in the final guidelines (Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eExperts were also asked to vote regarding the potential inclusion of the five items collectively identified as referring more to set than to setting due to their subjectivity. Despite the study\u0026rsquo;s initial focus on setting variables, only 15% of experts voted to exclude these items from the guidelines. Rather, experts supported keeping these items as a standard component of the guidelines (46%) or as an optional subsection pertaining to \u0026lsquo;Participant Experience\u0026rsquo; (39%). Based on these responses, these five items examining subjective experiences were included in the final section of the guidelines (Table 3).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e(Table 2)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOverall, Round Three resulted in 13 additional items meeting criteria for acceptance. Added to the 17 accepted items from Round Two, this produced the 30-item \u003cem\u003ePreliminary guidelines for reporting setting in psychedelic clinical trials\u003c/em\u003e, reported in appendix 1 with an overview of each items\u0026rsquo; progression from Round One to Round Four.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRound Four\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eResults from the final round (N = 62) are presented in full in appendix 1. At least 95% of experts reported being satisfied or very satisfied with the preliminary guidelines, and either agreed or strongly agreed that they reflect what is important for reporting in psychedelic clinical trials. Seventy-four percent of experts said they would \u0026ldquo;definitely\u0026rdquo; use the guidelines and 25% said they would \u0026ldquo;consider it\u0026rdquo;; only one (2%) expert reported they would not.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRegarding the study methodology and process, at least 95% of experts rated the survey instructions as clear, the study structure as generally satisfactory, and both deadlines and time commitments as reasonable. Similarly, at least 95% evaluated the study as successful in identifying areas of agreement and disagreement, allowing opinions to be comfortably expressed, and ensuring that diverse voices had been adequately heard. Finally, 68% percent of experts reported that their conceptualization of setting had changed as a result of the study process, mostly in terms of the granularity, scope, and depth with which they considered setting-related variables.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe Reporting of Setting in Psychedelic Clinical Trials Guidelines\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe final Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) 2024 guidelines are presented in Table 3 (fillable format in appendix 2). They were collaboratively refined from the preliminary guidelines by the study leads and experts. The guidelines are accompanied by a comprehensive explanatory document (appendix 3), also produced collaboratively, which provides detailed descriptions of each item, suggested reporting prompts, supporting expert responses and a brief summary of the literature on the 30 ReSPCT items.\u003c/p\u003e\n\u003cp\u003eThe ReSPCT guidelines are composed of 30 items divided into four sections. The first section describes the physical and sensory environments to which participants are exposed during a dosing session, such as the study location, decorations, and sensory reduction devices available to participants. The second section pertains to the dosing procedure, including the people present, music provided, and interventions performed. The third section regards the trial\u0026rsquo;s broader therapeutic framework and protocol, including preparatory and integration activities,\u003csup\u003e1\u003c/sup\u003e and study personnel qualifications. The final section explores key aspects of participants\u0026rsquo; subjective experiences, including evaluations of therapeutic alliances, comfort, and both physical and psychological safety.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e(Table 3)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe Conceptualization of Set and Setting\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs detailed above, an emergent finding of the study\u0026rsquo;s first three rounds was a lack of clarity and consensus regarding the conceptual boundaries between \u0026lsquo;set\u0026rsquo; and \u0026lsquo;setting\u0026rsquo;. Additional questions were thus posed to experts in Round Four to explore perspectives on this influential concept (Figure 2). When asked to rate their agreement with the statement that set and setting can be studied separately, almost equal proportions agreed/strongly agreed (37%) as disagreed/strongly disagreed (42%). Experts were also asked to estimate the conceptual overlap between set and setting, from 0% to 100%. Responses again ranged widely, with nearly equal proportions of experts estimating conceptual overlap as 20-40%, 40-60% or 60-80%, yielding an average overlap rating of 49%.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAdditionally, experts were asked to define the temporal boundaries of setting across the standard phases of psychedelic clinical trials. Sixty-eight percent agreed that setting spans from the start of a clinical trial\u0026rsquo;s recruitment to the end of its follow-up. Only 16% considered setting as limited to the trial\u0026rsquo;s treatment phase \u0026ndash; generally entailing preparation, dosing, and integration subphases\u003csup\u003e1\u003c/sup\u003e \u0026ndash; and 10% considered setting to be confined to the actual dosing session.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e(Figure 2)\u003c/strong\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003e\u003cem\u003eThe ReSPCT guidelines\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe 30-item ReSPCT guidelines provide a new standard for the reporting of extra-pharmacological variables in psychedelic clinical trials, derived from an international Delphi-consensus study of experts from 17 different countries and 50 different institutions. The contributing clinicians, researchers, and past trial participants were selected to represent diverse forms of knowledge and perspectives, which were exchanged and debated throughout the iterative Delphi process. The final items span the physical environment of dosing sessions to important aspects of participants\u0026rsquo; experiences of psychedelic clinical trial settings.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe items of the ReSPCT guidelines are intended to be reported in the texts or supplements of future studies alongside a completed checklist (appendix 2). This practice aims to strengthen the design and documentation of clinical research on psychedelic drugs, and thereby improve the transparency, reproducibility, and validity of this rapidly evolving field.\u003csup\u003e12, 33\u003c/sup\u003e Adoption of these guidelines may also facilitate data comparison and aggregation across different groups and institutions,\u003csup\u003e34\u003c/sup\u003e and inform future dismantling and therapeutic studies\u003csup\u003e6\u003c/sup\u003e. Indeed, such issues recently prompted the US Food and Drug Administration\u0026nbsp;to describe psychedelic therapies as a \u0026lsquo;black box\u0026rsquo;\u003csup\u003e35\u003c/sup\u003e and contributed to their recent rejection of MDMA-assisted therapy as a treatment for post-traumatic stress disorder.\u003csup\u003e36\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThese guidelines were designed specifically for psychedelic clinical trials but may be adapted to other clinical and research contexts. For instance, they may be valuable in research involving other acutely psychoactive substance, given that potent drug-context interactions have been found with multiple non-psychedelic substances \u0026ndash; including alcohol, antidepressants, and opiates.\u003csup\u003e11\u003c/sup\u003e Additionally, the guidelines may facilitate more observational or pragmatic forms for psychedelic research.\u003csup\u003e37\u003c/sup\u003e The challenges of blinding\u0026nbsp;in psychedelic research may prove to be insurmontable;\u003csup\u003e38\u003c/sup\u003e the ReSPCT guidelines could therefore support pragmatic study designs that prioritize the careful curation and systematic reporting of contextual variables over efforts to mask or minimize their influences.\u003csup\u003e37, 39\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConceptual challenges and heterogenous views on set and setting\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study revealed diverse initial views regarding the relative importance of various components of settings. Some of the final items, such as music and access to nature, were independently suggested by most experts in the first round and retained high agreement throughout the study. Others, such as narrative framings, and the positioning of people in treatment rooms, were mentioned by few but rapidly reached consensus thresholds thereafter.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTwo items that feature in the ReSPCT guidelines initially failed to reach whole-group consensus but were rescued by the debate process. For instance, in Round Two, \u0026lsquo;Cultural competence and safety\u0026rsquo; (Item 25) reached consensus only in two subgroups. Cultural competence refers to a study team\u0026rsquo;s ability to care for participants with diverse values, beliefs, and behaviors,\u003csup\u003e40\u003c/sup\u003e while cultural safety focuses on increasing health equity by encouraging healthcare professionals to examine power imbalances in patient-provider interactions.\u003csup\u003e41\u003c/sup\u003e In Round Three, multiple experts supported this item\u0026rsquo;s importance, citing concerns regarding power imbalances and a lack of diversity in psychedelic clinical and research contexts.\u003csup\u003e42-45\u003c/sup\u003e As a result, the item\u0026rsquo;s whole-group rating increased from 50% to 73%, leading to its inclusion in the final guidelines.\u003c/p\u003e\n\u003cp\u003eThe study process also identified challenges associated with how set and setting is currently conceptualized. Despite the study\u0026rsquo;s original focus on setting variables, early results and a subsequent vote led to the inclusion of five items that align more closely with the concept of (mind)set in the final guidelines\u0026rsquo; last section. In contrast to the consensus achieved regarding the relative importance of specific extra-pharmacological variables, expert views on the concept of set and setting itself remained highly heterogenous. For instance, in the final round, expert views were evenly divided regarding the perceived overlap and the separability of set and setting variables.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe discrepant understandings of \u0026lsquo;set and setting\u0026rsquo; amongst experts likely contributes to inconsistent reporting practices in psychedelic clinical trials. The ReSPCT guidelines aim to bypass this confusion with an explicit list of 30 key extrapharmacological factors that are understood as interrelated, rather than as dichotomous. I.e., a study\u0026rsquo;s environment and therapeutic approach may interactively shape participant experiences, and those experiences may influence how extra-pharmacological factors are perceived or even adapted. The guidelines thus prioritize specificity over simplicity in the aim of improving psychedelic clinical research practices. Further study is needed to evaluate if the utility of \u0026lsquo;set and setting\u0026rsquo; outweighs its conceptual confusion in other contexts.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLimitations\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDespite the study\u0026rsquo;s strengths, several limitations must be acknowledged. First, the Delphi process was entirely survey-based, which may have reduced the spontaneity and depth of dialogue that can occur in face-to-face interactions. Secondly, the study\u0026rsquo;s sample of experts did not represent the full diversity of perspectives on these drugs. For instance, the study\u0026rsquo;s focus on clinical trials excluded broader, non-clinical perspectives on variables that shape psychedelic experiences. It also resulted in most experts being relatively young and originating from Western countries, where psychedelic clinical research is currently most highly concentrated. Relatedly, the study\u0026rsquo;s definition of expertise reproduced known issues of the psychedelic field,\u003csup\u003e43, 44\u003c/sup\u003e namely the current lack of racial diversity amongst psychedelic researchers and trial participants. This limitation was only partially overcome through the study\u0026rsquo;s subgroup process, given that 75-80% of the sample was White. Finally, expertise does not necessarily equate to truth, and opinions of current psychedelic experts must be situated in the current historical moment and body of knowledge. Further empirical research is needed to evaluate the actual importance of the variables that have been included in, or excluded from, the ReSPCT guidelines, and to discern those most relevant to clinical outcomes.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe ReSPCT guidelines aim to advance the study of psychedelic drugs and therapies just as reporting guidelines have improved the transparency and interpretability of other complex clinical interventions.\u003csup\u003e15, 16, 46\u003c/sup\u003e Its 30 items reflect a necessary, if preliminary, expert consensus regarding the most important contextual factors to report in studies of psychedelic drugs. The accompanying explanatory document serves to facilitate reporting and guide future research by synthesizing the current literature regarding contextual influences on psychedelic drug effects. Routine utilization of these guidelines could significantly improve the rigor of psychedelic research, mitigate the ambiguities of current understandings of set and setting, and potentially facilitate the future clinical implementation of these promising therapies in safe, transparent, and effective ways.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to acknowledge the contributions of the following individuals to the Delphi process: Dr. Friedericke Meckel, Dr. Simon Amar, Dr. Willoughby Britton, and Mr. Thomas Hartle. Mr Hartle, who recently passed away, was the first Canadian to receive psilocybin for end-of-life distress associated with a terminal cancer diagnosis. He was a strong advocate for psychedelic research and a valued contributor to this study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData sharing statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDeidentified data collected as part of the study, as well as additional study materials such as study surveys, will be made available upon reasonable requests for purposes deemed to be scientifically valid by the study authors. Requests for data or additional study materials can be made to the corresponding author. Sharing of data will be contingent on an executed data transfer agreement.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDeclarations of interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no conflicts of interest to declare.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRole of the funding source\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFunds from the Societal Engagement Seed Fund, Imperial College London, were used to remunerate past clinical trial participants for their time completing the four sets of surveys.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSchenberg EE. Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development. Front Pharmacol. 2018;9:733.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePronovost-Morgan C, Hartogsohn I, Ramaekers JG. Harnessing placebo: Lessons from psychedelic science. 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Bmj. 2008;337.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cdiv id=\"20\" class=\"btn-xs-small Annotation tooltipped\" data-position=\"top\" data-tooltip=\"\"\u003e\u0026nbsp;\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eExpert participants\u0026rsquo; sociodemographic and professional characteristics in the first and final study rounds.\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth colspan=\"2\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eExpert demographics\u003c/div\u003e\n \u003c/th\u003e\n \u003cth colspan=\"2\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eRound One (N\u0026thinsp;=\u0026thinsp;89)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth colspan=\"2\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eRound Four (N\u0026thinsp;=\u0026thinsp;62)\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCategory\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCount\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(Percentage)\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCount\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(Percentage)\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eGender identity\u003c/span\u003e\u003c/div\u003e\n 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\u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eAge\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e25\u0026ndash;34\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e19\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(21\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e11\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(17\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e35\u0026ndash;44\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e33\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(37\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e25\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(40\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e45\u0026ndash;54\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e21\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(23\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e13\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(21\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e55\u0026ndash;64\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(9\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(11\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e65+\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(9\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(9\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eEthnicity\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAsian (Indian, Pakistani, Bangladeshi, Chinese, any other Asian background)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBlack / African / Caribbean\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(0\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eHispanic / Latino\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eIndigenous\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(7\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(6\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMiddle Eastern or North African\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMediterranean\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(2\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMixed two or more ethnic groups\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(5\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eWhite\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e66\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(74\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e50\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(80\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePrefer not to say\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eNationality\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eUnited States of America\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e22\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(24\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e16\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(25\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eUnited Kingdom of Great Britain and Northern Ireland\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e17\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(19\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e14\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(22\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCanada\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e17\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(19\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e12\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(19\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAustralia\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(5\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(4\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSwitzerland\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(5\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(6\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNetherlands\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(4\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(4\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBrazil\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(4\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eGermany\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(0\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSpain\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDenmark\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(2\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e0\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(0\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eIsrael\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(2\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(1\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eOther: Chile, France, Greece, Hungary, Mexico, South Africa\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(6\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(8\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eEducation level\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBachelor\u0026apos;s Degree\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(9\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(11\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMaster\u0026apos;s Degree\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e18\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(20\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e11\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(17\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDoctorate or Professional Degree\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e59\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(67\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e40\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(64\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eVocational school\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(4\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eExpert type*\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eResearcher\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e64\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(71\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e42\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(67\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eClinician\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e39\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(43\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e24\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(38\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eParticipant\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e19\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(21\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e16\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(25\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eField of expertise*\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eScience\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e62\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(69\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e37\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(59\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsychology\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e42\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(47\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e28\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(45\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSocial science (other than psychology)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e44\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(49\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e31\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(50\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePlant medicine\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(4\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(3\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eN/A\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e10\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(11\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(14\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eYears working in psychedelic field\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1 to 5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e26\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(29\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e20\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(32\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5 to 10\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e19\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(21\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e11\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(17\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e10 to 15\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e12\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(13\u0026middot;5%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(12\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e15+\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e32\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(36\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e23\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(37\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eSelf-reported form of psychedelic expertise*\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLived experience\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e50\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(56\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e41\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(66\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSet and setting\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e46\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(51\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e31\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(50\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsychedelic therapy in a clinical context\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e45\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(50\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e33\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(53\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eConducting clinical trials\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e30\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(33\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e21\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(33\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsychedelic therapy in non-clinical contexts\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e27\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(30\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e19\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(30.6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsychedelic psychopharmacology\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e23\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(25\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e15\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(24\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDrug policy and/or harm reduction\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e21\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(23\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e17\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(27\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsychedelic neuroimaging\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e14\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(15\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(12\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eOther: physiotherapy, data science, ancestral medicine, design, literature, arts and aesthetics, spiritual care, nursing, social work.\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e13\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(14\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(11\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eSelf-reported expertise regarding specific psychedelic drugs*\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsilocybin\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e80\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(89\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e54\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(87\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMDMA\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e52\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(58\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e37\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(59\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLSD\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e48\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(53\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e33\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(53\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAyahuasca\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e40\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(44\u0026middot;9%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e29\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(46\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eKetamine\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e38\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(42\u0026middot;7%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e29\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(46\u0026middot;8%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDMT\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e33\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(37\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e23\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(37\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMescaline\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e26\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(29\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e20\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(32\u0026middot;3%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5-MeO-DMT\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e18\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(20\u0026middot;2%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e12\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(19\u0026middot;4%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eIbogaine\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(5\u0026middot;6%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(8\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eOther: cannabis, tobacco, Salvinorin A, 3,4-Methylenedioxyamphetamine (MDA), \u003cspan class=\"Italic\"\u003eN,N\u003c/span\u003e-Dipropyltryptamine (DBP), Nitrous oxide.\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(9\u0026middot;0%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e(8\u0026middot;1%)\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\"\u003e*Percentages do not amount to 100% as experts may have endorsed more than one form of expertise.\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eItems debated in Round 3 due to reaching consensus threshold in one or more subgroups but not the overall group. *Cultural competence and cultural safety were originally two separate items that were merged as per expert feedback.\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDebated item\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eRatings in overall group\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eRatings in groups in which item met consensus threshold\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eReasons provided for (and against) item\u0026rsquo;s inclusion in reporting guidelines\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth colspan=\"4\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eItems that ultimately achieved consensus\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBathroom facilities\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e60%\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBIPOC or mixed ethnicity: 14/18 (78%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePast trial participants: 16/20\u0026nbsp;(80%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBathroom accessibility and privacy may influence the experiences of participants in vulnerable states induced by psychedelic drugs.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eFacilitators\u0026rsquo; cultural competence and safety*\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e52% competence\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e47%\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003esafety\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBIPOC or mixed ethnicity:\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e14/18 (78%) competence\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003e13/18 (72%) safety\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePlant medicine: 4/4 (100%) both\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eNon-binary: 3/4 (75%) safety\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eStudy facilitators\u0026rsquo; capacity to provide culturally competent and safe care may impact how participants from diverse backgrounds experience the study, and have important ramifications on the broader field\u0026rsquo;s diversity, equity, and inclusivity.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eItems that ultimately failed to achieve consensus\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eOdours, scents, smells\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e58%\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePast trial participants: 15/20 (75%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePlant medicine: 4/4 (100%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eThe capacity for olfactory stimuli to invoke memories and/or influence emotions may be heightened under the effects of psychedelic drugs.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTemperature\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e58%\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBIPOC or mixed ethnicity: 15/18 (83%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePast trial participants: 14/20 (70%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eSocial sciences: 19/26 (73%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePlant medicine: 4/4 (100%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTemperature may influence participant comfort and sense of control over their environment, and thereby shape their psychedelic experience.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eFacilitators demographics and cultural backgrounds\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e60%\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNon-binary: 3/4 (75%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eBIPOC or mixed ethnicity: 14/18 (78%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eClinicians: 22/31 (71%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eNo clin. trial experience: 19/25 (76%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eStudy facilitators\u0026rsquo; backgrounds and beliefs may directly or indirectly shape psychedelic experiences through interactions with participants. However, collecting and reporting such information may raise privacy concerns.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSociocultural context\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e56%\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNon-binary: 3/4 (75%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eBIPOC or mixed ethnicity: 15/18 (83%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePast trial participants: 14/20 (70%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePlant medicine: 4/4 (100%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsychedelic experiences may be influenced by both current and past societal factors, including media coverage, legal statuses, and mainstream perceptions of psychedelic drugs. However, such influences may be too broad and complex to be accurately captured and reported.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSocial determinants of health\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e68%\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMale: 27/38 (71%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eNon-binary: 3/4 (75%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eBIPOC or mixed ethnicity: 16/18 (89%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eClinicians: 23/31 (74%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eSocial sciences: 22/26 (85%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003ePlant medicine: 4/4 (100%)\u003c/div\u003e\n \u003cdiv class=\"SimplePara\"\u003eNo clin. trial experience: 19/25 (76%)\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSocial determinants of health exert important influences on mental and physical wellbeing, and likely influence psychedelic clinical trial outcomes. However, social determinants are defined in diverse ways, and they may be challenging to accurately report due to their breadth and complexity.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eThe Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) 2024 guidelines. \u003cspan class=\"Bold\"\u003eCaption\u003c/span\u003e: The ReSPCT guidelines serve as a reporting tool for settings in clinical trials with psychedelics. Each item should be reported in the main text or supplement of the resultant publication(s), the location of which should be indicated in the accompanying checklist (appendix 2). The supporting explanatory document (appendix 3) provides details and further guidance, including relevant research and suggested reporting prompts for each item.\u003c/div\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eItem\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eItem Number\u003c/div\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eItem details\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth colspan=\"3\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePhysical environment\u003c/div\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLocation\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e1\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLocation of the trial, and whether indoors/outdoors and urban/rural/suburban.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAmbiance\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e2\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eRoom ambiance curated by the study team.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAccess to nature\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e3\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSources of nature or natural elements that are physically or visually accessible to participants.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eObjects and decorations\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e4\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eObjects and decorations in the room.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLighting\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e5\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eRoom lighting and adjustability.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSensory reduction\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e6\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eSensory reduction used, such as headphones and eyeshades.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eBathroom facilities\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e7\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLevel of bathroom accessibility, privacy, and safety.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eDosing session procedure\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNumber and roles of people present\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e8\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNumber and roles of people present, including participants, study staff and informal support.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePositioning\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e9\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eRelative position of people in the room, and what participants were positioned on (e.g., bed, mat, couch).\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eFocus and main activities\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e10\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eFocus (internal or external) and main activities of the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMusic or soundscapes\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e11\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMusic or soundscapes that accompanied the dosing experience.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eInterpersonal interventions\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e12\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eVerbal or physical interpersonal interventions used throughout the session, and how consent was obtained.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eParticipant autonomy, control, and agency\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e13\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eLevel of participant control and agency over activities and environment of the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDosing regimen\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e14\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDosing regimen, including drug dose(s), frequency, route of administration and length of the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMedical and experimental procedures or assessments\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e15\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eMedical and experimental procedures or assessments performed during the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePre- and post-dosing protocol\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e16\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eActivities that took place immediately prior to- or post-dosing, including participant arrival and release conditions.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePotential disturbances or interruptions\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e17\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eDisturbances or interruptions that may have impacted the quality of the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eTherapeutic framework and protocol\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTherapeutic or guiding approach\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e18\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTherapeutic or guiding approach used throughout the study, if any, with the accompanying manual or protocol.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNarrative framing\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e19\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eFraming of the trial intervention by the study team, including the short- and long-term drug effects.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNumber of sessions\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e20\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eNumber and length of preparation, dosing, and integration sessions.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePreparation protocol\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e21\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eActivities performed during the preparation sessions.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eIntegration protocol\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e22\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eActivities performed during the integration sessions.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eAdditional support or follow-up\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e23\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eFormal or informal support or follow-up offered to participants after the end of the trial, including in the case of adverse events.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eStudy personnel qualifications\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e24\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eThe credentials, training, and expertise of personnel providing the study intervention or care.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eCultural competence and safety\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e25\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eStudy team\u0026apos;s level of cultural competence and efforts towards cultural safety.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e\u003cspan class=\"Bold\"\u003eSubjective experiences\u003c/span\u003e\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTherapeutic alliance\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e26\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTherapeutic alliance between participants and facilitators throughout the intervention.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eTrust\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e27\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eParticipant\u0026apos;s level of trust throughout the intervention.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePhysical comfort\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e28\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eParticipant\u0026apos;s level of physical comfort during the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePhysical safety\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e29\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eParticipant\u0026apos;s sense of physical safety during the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003ePsychological and cultural safety\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003e30\u003c/div\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cdiv class=\"SimplePara\"\u003eParticipant\u0026apos;s sense of psychological and cultural safety with the people present during the dosing session.\u003c/div\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"Full Author List","content":"\u003cp\u003eThe full author list can be found in the supplemental file \"Title_page.docx\". \u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"nature-portfolio","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"","title":"Nature Portfolio","twitterHandle":"","acdcEnabled":false,"dfaEnabled":false,"editorialSystem":"ejp","reportingPortfolio":"","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-5428217/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5428217/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePsychedelic substances exhibit complex interactions with the ‘set and setting’ of use, i.e., the internal state of the user and the external environment in which a psychedelic experience takes place. Despite the known importance of these contextual variables, psychedelic research has suffered from methodological weaknesses in reporting extra-pharmacological factors and from a lack of consensus regarding their relative importance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study aimed to generate consensus-based guidelines for the reporting of settings in psychedelic clinical research, according to a diverse international group of psychedelic researchers, clinicians, and past trial participants. We conducted a large international Delphi consensus study composed of four iterative rounds of quasi-anonymous online surveys and facilitated debates.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFindings\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEighty-nine experts from 17 countries initially identified hundreds of potentially important psychedelic setting variables. These 770 responses were synthesized into 49 distinct items that were then rated, debated, and refined in subsequent rounds. The process resulted in 30 extra-pharmacological variables reaching pre-defined consensus thresholds: rated “important” or “very important” for reporting by at least 70% of experts. These items compose the Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) guidelines, categorized into: physical environment, dosing session procedure, therapeutic framework and protocol, and subjective experiences. Emergent study findings reveal significant ambiguities in current conceptualizations of set and setting.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterpretation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe ReSPCT guidelines and its accompanying explanatory document provide a new standard for the design and documentation of extra-pharmacological variables in psychedelic clinical research. Drug-context interactions warrant further attention to ensure the methodological rigor of psychedelic research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSocietal Engagement Seed Fund, Imperial College London.\u003c/p\u003e","manuscriptTitle":"The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) Guidelines: An international Delphi consensus study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-18 11:47:53","doi":"10.21203/rs.3.rs-5428217/v1","editorialEvents":[],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"nature-medicine","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"nm","sideBox":"Learn more about [Nature Medicine](http://www.nature.com/nm/)","snPcode":"","submissionUrl":"","title":"Nature Medicine","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature Research","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"df351528-20d3-4218-ab05-8492aad33480","owner":[],"postedDate":"November 18th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":40113962,"name":"Health sciences/Medical research/Clinical trial design/Randomized controlled trials"},{"id":40113963,"name":"Biological sciences/Psychology"},{"id":40113964,"name":"Scientific community and society/Social sciences/Interdisciplinary studies"}],"tags":[],"updatedAt":"2025-06-04T07:08:58+00:00","versionOfRecord":{"articleIdentity":"rs-5428217","link":"https://doi.org/10.1038/s41591-025-03685-9","journal":{"identity":"nature-medicine","isVorOnly":false,"title":"Nature Medicine"},"publishedOn":"2025-06-03 04:00:00","publishedOnDateReadable":"June 3rd, 2025"},"versionCreatedAt":"2024-11-18 11:47:53","video":"","vorDoi":"10.1038/s41591-025-03685-9","vorDoiUrl":"https://doi.org/10.1038/s41591-025-03685-9","workflowStages":[]},"version":"v1","identity":"rs-5428217","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5428217","identity":"rs-5428217","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}