drugset / Trial / NCT06306443

Buprenorphine for Individuals in Jail

NCT06306443

Phase 3 Recruiting 240 enrolled Friends Research Institute, Inc.
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

EvaluationDrugModalityDoseRoute
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