Clinical Trial

Injectable Buprenorphine in Prison: A Preference Trial

Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community. The main question it aims to answer are: How do Sublocade and Brixadi compare in terms of feasibility, acceptability, and effectiveness? Does giving people a choice of medication affect how well they stay in treatment? Using a partially randomized preference trial approach, there will be a comparison between participants who choose their XR-B formulation to those who are randomly assigned to see if patient preference influences treatment outcomes. The trial is a hybrid implementation-effectiveness trial. Participants will: * Choose which medication they prefer or be randomly assigned if they don't have a preference. * Receive monthly injections of either Sublocade or Brixadi before and after release from prison. * Complete surveys and clinical assessments on treatment experience and acceptability. * Be monitored for treatment retention, opioid use, and adverse events for six months post-release. Researchers will compare the two treatments to see which one works better for people leaving prison and if allowing people to choose their treatment improves results.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-14; most recent amendment 2026-05-13.
Status change: Not Yet Recruiting → Recruiting 2026-05-13
Trial Details
NCT Number NCT06880718
Lead Sponsor Lifespan
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid Use Disorder, Incarceration, Medications for Opioid Use Disorder, Buprenorphine
Enrollment 60 participants
Start Date 2026-02-18
Primary Completion 2027-01 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-15