Buprenorphine for Individuals in Jail
Friends Research Institute, Inc. · NCT06306443
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
Similar studies in Maryland
All healthy volunteers studies in Maryland →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
AstraZeneca
- Location
- Brooklyn, MD + 1 other US site
- Eligibility basics
- Ages 18–55
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Location
- Bethesda, MD
- Eligibility basics
- Ages 21–60
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Study of Intravenous ZMA001 in Healthy Subjects
National Heart, Lung, and Blood Institute (NHLBI)
- Location
- Bethesda, MD
- Eligibility basics
- Ages 18–60
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Johns Hopkins University
- Location
- Baltimore, MD
- Eligibility basics
- Ages 21–55