Telemedicine XR-B for Individuals in Jail

NCT07524738 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: Telemed XR-B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open label pilot study of 30 incarcerated men and women receiving sublingual buprenorphine (SL-B) in jail who will voluntarily switch to extended-release buprenorphine (BRIXADI) using telemedicine prior to release. Individuals will receive weekly XR-B and at least one monthly XR-B injection prior to release. Individuals will be linked to a community treatment provider where they will continue their treatment (buprenorphine) post-release. Participants will be assessed at 1,2-, and 3-months post release

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• medication adherence

  number of extended-release buprenorphine injections completed

  three months post-release

Secondary Outcomes (3)

• illicit opioid use

  three months post-release

• Urine toxicology

  three months post-release

• overdose

  three months post-release

Study Arms (1)

XR-B

EXPERIMENTAL

extended-release buprenorphine

Drug: Extended Release Buprenorphine

Interventions

Extended Release Buprenorphine DRUG

extended-release buprenorphine using telemedicine in jail

XR-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female inmates at the participating jail who are eligible for release within 120 days (sentenced and/or pretrial \[note: individuals who might be sentenced to state/federal prison will be excluded; individuals with detainers in another county will also be excluded\]); 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 treatment as determined by medical evaluation;
• Willingness to enroll in XR-B treatment in jail and continue in the community;

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 3 months);
• Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone).

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead

Study Sites (1)

Allegany County Detention Center

Cumberland, Maryland, 21502, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: extended-release buprenorphine

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)