Recruiting
Phase 3

XR-B vs. SL-B

Sponsor:

Friends Research Institute, Inc.

Code:

NCT06306443

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

extended-release buprenorphine (XR-B)

Study Details

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

Study ID

NCT06306443

Start date

Jun 20, 2025

Status verified date

May, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: extended-release buprenorphine (XR-B)

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.

active comparator: sublingual buprenorphine (SL-B)

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.

Interventions

extended-release buprenorphine (XR-B)

buprenorphine

Primary outcome measure

  • urine toxicology [ Time Frame: 12-months ]
  • days of opioid use [ Time Frame: 12-months ]
  • time to opioid relapse [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Michael Gordon, DPA

4108373977mgordon@friendsresearch.org

Thomas R Blue, PhD

4108373977tblue@friendsresearch.org

Locations

Friends Research Institute

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Michael Gordon

4108373977mgordon@friendsresearch.org

Baltimore Central Booking & Intake Center

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Michael Gordon, DPA

4108373977mgordon@friendsresearch.org

Thomas R Blue, PhD

4108373977tblue@friendsresearch.org

More Information

Sponsor

Friends Research Institute, Inc.

Last update posted

Jun 4, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Friends Research Institute, Inc. on 2026-06-04.