NCT06880718 Injectable Buprenorphine in Prison: A Preference Trial
| NCT ID | NCT06880718 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lifespan |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2026-02-18 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06880718 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06880718 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06880718 currently recruiting?
Yes, NCT06880718 is actively recruiting participants. Contact the research team at justin_berk@brown.edu for enrollment information.
Where is the NCT06880718 trial being conducted?
This trial is being conducted at Cranston, United States.
Who is sponsoring the NCT06880718 clinical trial?
NCT06880718 is sponsored by Lifespan. The trial plans to enroll 60 participants.