Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
Status:
RECRUITING
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
Summary
This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial \~2-week period of induction/stabilization. The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings.
Phase:
PHASE3
Details
Lead Sponsor:
Yih-Ing Hser
Collaborators:
Cornell University National Institute on Drug Abuse (NIDA) National Institutes of Health (NIH) Oregon Health and Science University RAND The Emmes Company, LLC University of California, Los Angeles University of Illinois at Chicago University of Washington West Virginia University