Buprenorphine for Individuals in Jail

Last updated: January 30, 2026
Sponsor: Friends Research Institute, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Opioid Use Disorder

Treatment

extended-release buprenorphine (XR-B)

Clinical Study ID

NCT06306443
20235453
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult male or female inmates at participating jail who are eligible for releasewithin 120 days (sentenced and/or pretrial [note: individuals who might be sentencedto state/federal prison will be excluded]); Those individuals who are pre-trialand/or sentenced who are completing their sentence in the community (probation,parole, home detention, electronic monitoring, drug or other treatment court [orequivalent]) will be eligible to participate;

  • History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioiduse disorder at the time of incarceration; individuals not meeting theopioid-disorder criterion will be eligible if they were treated in an opioid agonisttreatment program during the year before incarceration);

  • Suitability for XR-B and/or SL-B treatment as determined by medical evaluation;

  • Willingness to enroll in XR-B or SL-B treatment in jail and continue in thecommunity;

  • Planning to live in Baltimore City or the Baltimore Region;

Exclusion

Exclusion Criteria:

  • Liver function test levels greater than 5 times normal (if we are unable to obtainlabs, a determination by the study physician will be made to allow inclusion);

  • Active medical illness that may make participation hazardous (e.g., unstablediabetes, heart disease; moderate to severe renal impairment; adequately treatedmedical conditions are acceptable);

  • Conditions or medications that may predispose to QTc prolongation (personal orfamily history of long QT syndrome, hypokalemia, medications that prolong QTcinterval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics,antipsychotics and antidepressant);

  • Untreated psychiatric disorder that may make participation hazardous (e.g.,untreated psychosis, bipolar disorder with mania; adequately treated psychiatricdisorders and appropriate psychotropic medications will be allowed);

  • History of allergic reaction to buprenorphine;

  • Suicidal ideation (within the past 6 months);

  • Inability to pass a study enrollment quiz; and

  • Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone).

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: extended-release buprenorphine (XR-B)
Phase: 3
Study Start date:
July 01, 2025
Estimated Completion Date:
December 31, 2029

Study 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

Connect with a study center

  • Baltimore Central Booking & Intake Center

    Baltimore, Maryland 21202
    United States

    Site Not Available

  • Friends Research Institute

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Baltimore Central Booking & Intake Center

    Baltimore 4347778, Maryland 4361885 21202
    United States

    Active - Recruiting

  • Friends Research Institute

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Active - Recruiting

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