NCT03033732.

Background and aims: Fentanyl is primarily responsible for the current phase of the overdose epidemic in North America. Despite the benefits of treatment with medications for opioid use disorder (MOUD), there are limited data on the association between fentanyl, MOUD type and treatment engagement. The objectives of this analysis were to measure the impact of baseline fentanyl exposure on initiation and discontinuation of MOUD among individuals with prescription-type opioid use disorder (POUD).Design, setting and participants: Secondary analysis of a Canadian multi-site randomized pragmatic trial conducted between 2017 and 2020. Of the 269 randomized participants, 65.4% were male, 67.3% self-identified as white and 55.4% had a positive fentanyl urine drug test (UDT) at baseline. Fentanyl-exposed participants were more likely to be younger, to self-identify as non-white, to be unemployed or homeless and to be currently using stimulants than non-fentanyl-exposed participants.Interventions: Flexible take-home dosing buprenorphine/naloxone or supervised methadone models of care for 24 weeks. Measurements: Outcomes were (1) MOUD initiation and (2) time to (a) assigned and (b) overall MOUD discontinuation. Independent variables were baseline fentanyl UDT (predictor) and assigned MOUD (effect modifier).

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Background Given the health and social harms of problematic substance use, randomized controlled trials (RCTs) are critical in developing and testing pharmacotherapies for substance use disorders. However, substance use RCTs can be challenging to conduct, considering the social and structural barriers to participating in research among people with substance use disorders (PSUD), including stigma, poverty, and criminalization—factors that can shape trial recruitment, enrollment, protocol adherence and study retention. Despite these barriers, adequate representation and participation of PSUD in RCT research is essential to assessing and developing treatments, and thus a deeper understanding of RCT participation dynamics among PSUD is needed to support clinical trial research. Methods We conducted a nested qualitative study within a Canadian, multisite, phase IV, open-label, pragmatic RCT that tested two approved opioid agonist treatments, methadone and buprenorphine/naloxone, among patients with prescription opioid use disorder. A subset of individuals ( n = 60) participating in this RCT were interviewed across four different regions in Canada at the beginning and end of their trial involvement, as well as study clinicians ( n = 16) and staff ( n = 16) operating the trial. Conclusion As a nested study within a real-world addiction medicine trial, this research offers an innovative approach to investigating the experiences, strategies, and challenges associated with RCTs among PSUD. While we acknowledge challenges related to the operations of multisite research and engaging marginalized populations in experimental research, this study has the potential to generate critical insights around the RCT experiences of PSUDs and trial staff to inform the conduct of future RCTs.