Buprenorphine for Individuals in Jail

Opioid Use Disorder Clinical Trial

Official title: A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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.

Aim 1. Compare the effectiveness of XR-B vs. SL-B Aim 2. To calculate the cost to the state and/or jail/city health system of implementing XR-B and SL-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective.

Aim 3. Explore barriers and facilitators to XR-B versus SL-B implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily versus XR-B buprenorphine dosing; and (5) patient preference for XR-B versus SL-B.

Primary Outcome. (a) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use using Timeline Followback; and iii. time to opioid relapse).

Secondary Outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use using Timeline Followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration).

Costs. (a) cost to the correctional system; (b) costs associated with community intervention ;

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

• NCT number: NCT06306443
• Study type: Interventional
• Source: Friends Research Institute, Inc.
• Contact: Michael Gordon, DPA
• Phone: 4108373977
• Email: mgordon@friendsresearch.org
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Completion date: December 31, 2028