Trials / Active Not Recruiting
Active Not RecruitingNCT07524738
Telemedicine XR-B for Individuals in Jail
An Open Label Pilot Study of Extended-release Buprenorphine (XR-B) Using Telemedicine With Individuals in Jail
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Friends Research Institute, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open label pilot study of 30 incarcerated men and women receiving sublingual buprenorphine (SL-B) in jail who will voluntarily switch to extended-release buprenorphine (BRIXADI) using telemedicine prior to release. Individuals will receive weekly XR-B and at least one monthly XR-B injection prior to release. Individuals will be linked to a community treatment provider where they will continue their treatment (buprenorphine) post-release. Participants will be assessed at 1,2-, and 3-months post release
Detailed description
This study is an open label pilot study of 30 incarcerated men and women receiving sublingual buprenorphine (SL-B) in jail who will voluntarily switch to extended-release buprenorphine (BRIXADI) using telemedicine prior to release. Individuals will receive weekly XR-B and at least one monthly XR-B injection prior to release. Individuals will be linked to a community treatment provider where they will continue their treatment (buprenorphine) post-release. Participants will be assessed at 1,2-, and 3-months post release.1) To determine the feasibility and willingness of individuals in jail to transition from telemedicine SL-B to XR-B and continue upon release in the community. 2\) To examine (a) pharmacotherapy adherence pre release and community injections received), b) illicit opioid urine test results; (c) self-reported illicit opioid use; d) re-arrest and reincarceration; e) non-fatal and fatal overdose. 3\) Explore barriers and facilitators to telemedicine XR-B implementation in jail: (1) telemedicine XR-B administration; (2) telemedicine staffing (both custody and medical); and (2) continuity of care after release to a community provider
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Extended Release Buprenorphine | extended-release buprenorphine using telemedicine in jail |
Timeline
- Start date
- 2025-06-01
- Primary completion
- 2026-07-01
- Completion
- 2026-09-01
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07524738. Inclusion in this directory is not an endorsement.