Buprenorphine for Individuals in Jail

NCT06306443 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20235453
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• urine toxicology

  positive urine drug screen for opioids

  12-months

• days of opioid use

  Number of days since last assessment

  12-months

• time to opioid relapse

  days from release from jail to first relapse event

  12-months

Secondary Outcomes (9)

• retention in buprenorphine treatment

  6-months

• urine toxicology for other illicit substance use

  12-months

• days of illicit substance use

  12-months

• overdose events

  12-months

• PROMIS Patient-Reported Outcomes Measurement Information System - physical health

  12-months

Study Arms (2)

extended-release buprenorphine (XR-B)

EXPERIMENTAL

Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.

Drug: extended-release buprenorphine (XR-B)

sublingual buprenorphine (SL-B)

ACTIVE COMPARATOR

Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone.

Drug: extended-release buprenorphine (XR-B)

Interventions

extended-release buprenorphine (XR-B) DRUG

buprenorphine

Also known as: sublingual buprenorphine (SL-B)

extended-release buprenorphine (XR-B); sublingual buprenorphine (SL-B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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).

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead

Study Sites (2)

Friends Research Institute

Baltimore, Maryland, 21201, United States

RECRUITING

Baltimore Central Booking & Intake Center

Baltimore, Maryland, 21202, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Michael Gordon, DPA

CONTACT

4108373977; mgordon@friendsresearch.org

Thomas R Blue, PhD

CONTACT

4108373977; tblue@friendsresearch.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)