A Randomised Clinical Trial of a Theory-Based Fentanyl Overdose Education and Fentanyl Test Strip Distribution Intervention to Reduce Rates of Opioid Overdose: Study Protocol for A Randomized Controlled Trial

Abstract Background: Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g. administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behaviour change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take home use among people who use drugs.Methods: Residents of Rhode Island aged 18–65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n=500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomised clinical trial with 12 months of post-randomisation follow-up. Eligible participants will be randomised (1:1) to receive either the RAPIDS intervention (i.e. fentanyl-specific overdose education, behaviour change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use), or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomisation. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at six- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalisation or emergency medical service utilisation) overdoses.Discussion: If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose. Trial Registration: clinicaltrials.gov: NCT04372238; 01 May 2020