Research Participation in Substance Use Disorder Trials: Design and Methods of a Multi-Site Nested Qualitative Study

Abstract

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.

Letter in Reply

“…S evere infections are prevalent in people who inject drugs (PWID), and studies have shown that co-occurring opioid and methamphetamine use is increasingly prevalent 1 and associated with poor health outcomes, including infectious complications and risky injection behaviors, 2 as well as lower rates of linkage to outpatient buprenorphine treatment compared with opioid use alone. 3 In patients who use opioids and are hospitalized for infectious complications of injection drug use, there is limited evidence that stimulant use is associated with worse outcomes in terms of infection treatment and retention in care.…”

“…However, we agree and acknowledge the importance of using longer, multidimensional, patient-centered, patient-reported experience assessments of this construct in future longitudinal studies in patients receiving opioid agonist therapies. Therefore, we conducted an ancillary nested qualitative study 2 to gain an in-depth understanding of the multidimensional perspectives of participants, as well as clinicians, regarding the interventions and their participation in the (Optimizing Patient Centered-care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse) study. We hoped that such a qualitative approach would provide complementary and richer data pertaining to participants' perspectives on opioid agonist therapies, which hopefully might contribute to future development of relevant measure.…”