RecruitingPhase 3NCT06306443

Buprenorphine for Individuals in Jail

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

Sponsor

Friends Research Institute, Inc.

Enrollment

240 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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).