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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mgordon@friendsresearch.org
• Phone: 4108373977

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.