Uncovered, underfunded, and undervalued: How policy contexts shape knowledge production in multi-site substance use trials
Year: 2026
Type: article
Abstract: BACKGROUND: Pragmatic trials evaluate the effectiveness or feasibility of a treatment in clinical practice. However, in substance use research, the "real world" is characterized by patterns of structural stigma embedded in everchanging drug policies and public perceptions that vary by jurisdiction. While such contextual influences typically go unmeasured in clinical research, these localized features may shape participants' trial experiences and outcomes, with relevance for the conduct of multisite trials and their results. METHODS: We conducted a nested qualitative study with people who use drugs (PWUD) enrolled in a multi-site, pragmatic randomized controlled trial testing models of care for opioid use disorder. We analyzed 115 semi-structured interviews from 75 participants across four Canadian provinces using a flexible coding approach and thematic analysis. RESULTS: We investigate how jurisdictional differences in treatment-related policies shaped pragmatic trial experiences. In Alberta, participants described abrupt loss of study medication coverage due to restrictive income assistance policies, which could lead to treatment interruption. In Ontario and Quebec, long wait times for medications motivated enrollment in the trial, which participants viewed as a faster pathway to care. In British Columbia, participants highlighted concerns with inadequate medication formulations and limited access to emerging treatments. These site-specific dynamics underscore how structural stigma and treatment policies can manifest in research to complicate trial conduct and the interpretation of findings. CONCLUSIONS: Jurisdictional policy contexts and embedded structural stigma shape participants' experiences with substance use treatment and, consequently, treatment trials, necessitating the consideration of trial results across research settings.
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,350
Awards: G2616988200, G4568233170, Prairie CRISM Node Proposal, Initiation of opioid agonist therapy with daily witnessed methadone or flexible take-home dosing of buprenorphine/naloxone for prescription opioid users: A pragmatic patient-centred randomized controlled trial- BC Addiction Network, G7015789249, Initiation of opioid agonist therapy with daily witnessed methadone or flexible take-home dosing of buprenorphine/naloxone for prescription opioid users: A pragmatic patient-centred randomized controlled trial-Ontario OCRINT, G8268289830, Initiation of opioid agonist therapy with daily witnessed methadone or flexible take-home dosing of buprenorphine/naloxone for prescription opioid users: A pragmatic patient-centred randomized controlled trial-QC/Maritimes, Initiation of opioid agonist therapy with daily witnessed methadone or flexible take-home dosing of buprenorphine/naloxone for prescription opioid users: A pragmatic patient-centred randomized controlled trial- Prairies
OpenAlex ID: W7154034772