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RecruitingAccepts healthy volunteersPhase 3

Buprenorphine for Individuals in Jail

Friends Research Institute, Inc. · NCT06306443

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 3
Target enrollment
240
US sites recruiting
2
Study start
June 20, 2025
Record last updated
June 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: extended-release buprenorphine (XR-B)

Conditions: Opioid Use Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial [note: individuals who might be sentenced to state/federal prison will be excluded]); Those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court [or equivalent]) will be eligible to participate;
  • History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment 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 the community;
  • Planning to live in Baltimore City or the Baltimore Region;

Exclusion Criteria

  • Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion);
  • Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable);
  • Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, 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 psychiatric disorders 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).

Recruiting US locations

  • Friends Research Institute

    Baltimore, MD 21201

    Site contact: Michael Gordon · 4108373977 · mgordon@friendsresearch.org

  • Baltimore Central Booking & Intake Center

    Baltimore, MD 21202

    Site contact: Michael Gordon, DPA · 4108373977 · mgordon@friendsresearch.org

Study contacts (from the official record)

  • Michael Gordon, DPA · 4108373977 · mgordon@friendsresearch.org
  • Thomas R Blue, PhD · 4108373977 · tblue@friendsresearch.org
Buprenorphine for Individuals in Jail (NCT06306443) | Bored Studies