Buprenorphine for Individuals in Jail

Recruiting now · Phase 3

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT06306443

Run by

Friends Research Institute, Inc.

People needed

240

Starts

2025-06-20

Expected to finish

2029-04-30

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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).

Where it is running

• Friends Research Institute — Baltimore, Maryland, United States (enrolling)
• Baltimore Central Booking & Intake Center — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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