Condition: Opioid Use Disorder · Incarceration · Medications for Opioid Use Disorder · Sponsor: Lifespan
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.
This description comes directly from the study's public registry record.
Justin Berk, MD MPH MBA · (401) 680-1074 · justin_berk@brown.edu
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| Rhode Island Department of Corrections | Cranston, Rhode Island, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06880718