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Injectable Buprenorphine in Prison: A Preference Trial

RecruitingPhase 4Ages 18 Years - anyAllLifespan
NCT06880718 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. be at least 18 years of age and incarcerated in the RIDOC facility, 2. be currently diagnosed with OUD and enrolled in the RIDOC MOUD program, 3. have an expected release date within 120 days of study enrollment, 4. have an interest in XR-B and 5. be English speaking Exclusion Criteria: 1. individuals who are pregnant or planning conception, 2. diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely, 3. have a release date within 21 days of initiation, or 4. have previously had an allergy to buprenorphine. Post-enrollment exclusion will include individuals if there is a change in release date beyond the 120 days and therefore no longer meet original inclusion criteria. These individuals would return to usual MOUD care.
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What it tests

  • Brixadi (Injectable Buprenorphine)
  • Sublocade
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Where

1 site
Rhode Island Department of Corrections
Cranston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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