Monthly extended‑release buprenorphine versus daily sublingual buprenorphine for jailed adults with opioid use disorder

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

This project will test whether monthly extended‑release buprenorphine or daily sublingual buprenorphine helps adults with moderate-to-severe opioid use disorder who are about to be released from jail stay in treatment and avoid relapse.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Friends Research Institute, Inc. (Academic / other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT06306443 on ClinicalTrials.gov

What this trial studies

This is an open‑label, randomized trial that will assign 240 adults incarcerated in a large metropolitan jail to either extended‑release buprenorphine (BRIXADI, XR‑B) or daily sublingual buprenorphine (SL‑B) while in jail. Participants will continue buprenorphine treatment in the community for six months after release and be followed with a safety visit at seven months and a final follow‑up at 12 months. Primary outcomes focus on illicit opioid use measured by urine testing, self‑reported days of use, and time to relapse; secondary outcomes include treatment retention and other substance use. The protocol also includes economic analyses of costs to local/state systems and qualitative work on implementation barriers and facilitators in the jail setting.

Who should consider this trial

Good fit: Adults incarcerated at participating Baltimore sites with moderate-to-severe opioid use disorder who are medically eligible for buprenorphine, expect release within 120 days, and plan to live in Baltimore City and continue treatment.

Not a fit: People who will be transferred to state or federal prison, do not plan to live in Baltimore after release, have medical contraindications to buprenorphine, or do not meet moderate/severe OUD criteria may not receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this could increase retention in buprenorphine treatment after release and reduce opioid relapse and overdose risk among people leaving jail.

How similar studies have performed: Prior correctional and community studies show that initiating buprenorphine in jail or at release reduces opioid use and overdose risk and that extended‑release formulations can improve retention, though direct head‑to‑head randomized trials in jails are limited.

Eligibility 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).

Where this trial is running

Baltimore, Maryland and 1 other locations

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

Study contacts

• Study coordinator: Michael Gordon, DPA

Conditions Opioid Use Disorder