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NCT06880718 · ClinicalTrials.gov registry record · Phase 4
Injectable Buprenorphine in Prison: A Preference Trial
A Phase 4 study, sponsored by Lifespan.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT06880718: Recruiting Phase 4 study, sponsored by Lifespan.
NCT06880718 is a Phase 4 study that is actively recruiting participants, run by Lifespan. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06880718, a Phase 4 study, is actively recruiting participants, sponsored by Lifespan.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Preliminary Effectiveness will be measured through rates of community treatment continuation post-release. Outpatient treatment engagement over the first three months post-release will be assessed using study records of CPC Recovery Clinic follow-up appointments. For patients that do not follow at the CPC Recovery Clinic, statewide administrative data from the Rhode Island Prescription Drug Monitoring Program (PDMP) database covering community pharmacy fills of buprenorphine products will be use
Interventions
- DRUG Brixadi (Injectable Buprenorphine)
- DRUG Sublocade
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-02-18 |
| Est. Completion | 2027-06 |
| Phase | Phase 4 |
What NCT06880718 shows while recruiting
NCT06880718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Brixadi (Injectable Buprenorphine) is the first listed.
NCT06880718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06880718 about?
NCT06880718 is a clinical study titled "Injectable Buprenorphine in Prison: A Preference Trial". 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 th...
What is the current status of trial NCT06880718?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2026-02-18. Estimated completion is 2027-06.
What interventions are being tested in trial NCT06880718?
The interventions under investigation include: Brixadi (Injectable Buprenorphine) (DRUG), Sublocade (DRUG).
Who is sponsoring clinical trial NCT06880718?
This trial is sponsored by Lifespan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06880718's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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