drugset / Trial / NCT06306443
Buprenorphine for Individuals in Jail
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.
Timeline
- Start
- 2025-06-20
- Primary completion
- 2029-01-01
- Completion
- 2029-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 2 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 4 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 64 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 96 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 128 mg | Other |