Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial

Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial | 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 Research Article Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial Ron G Thompson Jr., Mary Bollinger, Michael J Mancino, Deborah Hasin, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2511936/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 04 Apr, 2023 Read the published version in Trials → Version 1 posted 4 You are reading this latest preprint version Abstract Background: Opioids accounted for 75% of drug overdoses in the United States in 2020, with rural states particularly impacted by the opioid crisis. While medication assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD; and (2) evaluate the role of specific OpitMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention. Methods: We will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. Participants are English-speaking adults ages 18 or older recently enrolled in outpatient MOUD at one of our participating study clinics. Participants will be allocated via 1:1 randomized block design to (1) MOUD with adjunctive use of OptiMAT (MOUD+OptiMAT) or (2) MOUD without OptiMAT (MOUD-only). Our blinded research statistician will evaluate differences between the two groups in opioid misuse (as determined by quantitative urinalysis conducted by clinical lab staff blinded to group membership) during the 6-months following study enrolment. Secondary analyses will evaluate if OptiMAT-usage patterns within the MOUD+OptiMAT group predict opioid misuse or continued abstinence. Discussion: This study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone appbased interventions. Trial registration: ClinicalTrials.gov identifier: NCT05336188, registered March 21, 2022, https://clinicaltrials.gov/ct2/show/NCT05336188. Opioid-Related Disorders (D009293) Mobile Applications (D063731) Opiate Substitution Treatment (D058850) Smartphone (D000068997) Behavioural Therapy (D001521) Full Text Cite Share Download PDF Status: Published Journal Publication published 04 Apr, 2023 Read the published version in Trials → Version 1 posted Editorial decision: Minor revision 14 Feb, 2023 Reviewers agreed at journal 13 Feb, 2023 Editor assigned by journal 31 Jan, 2023 First submitted to journal 24 Jan, 2023 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-2511936","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":175757529,"identity":"f9b763e5-5871-4c69-9303-02eef3069a86","order_by":0,"name":"Ron G Thompson Jr.","email":"","orcid":"","institution":"University of Arkansas for Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Ron","middleName":"G","lastName":"Thompson","suffix":"Jr."},{"id":175757530,"identity":"0c6cd910-8aad-473a-be98-351ed4581437","order_by":1,"name":"Mary Bollinger","email":"","orcid":"","institution":"University of 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Disorders (D009293), Mobile Applications (D063731), Opiate Substitution Treatment (D058850), Smartphone (D000068997), Behavioural Therapy (D001521)","lastPublishedDoi":"10.21203/rs.3.rs-2511936/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2511936/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eOpioids accounted for 75% of drug overdoses in the United States in 2020, with rural states particularly impacted by the opioid crisis. While medication assisted treatment (MAT) with Suboxone remains one of the more efficacious treatments for opioid use disorder (OUD), approximately 40% of people receiving Suboxone for outpatient MAT for OUD (MOUD) relapse within the first 6 months of treatment. We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes. The aims of this study are to (1) evaluate the efficacy of adjunctive OptiMAT use in reducing opioid misuse among people receiving MOUD; and (2) evaluate the role of\u0026nbsp;specific OpitMAT features in reducing opioid misuse, including the use of GPS-driven just-in-time intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e We will conduct a two-arm, single-blind, randomized controlled trial of adults receiving outpatient MOUD in the greater Little Rock AR area. 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