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OpenTrials
Active, Not Recruiting

NCT Number: NCT07524738

Telemedicine XR-B for Individuals in Jail

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allegany County Detention Center

Cumberland, Maryland, 21502, United States

About this study

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.1) To determine the feasibility and willingness of individuals in jail to transition from telemedicine SL-B to XR-B and continue upon release in the community.

  • To examine (a) pharmacotherapy adherence pre release and community injections received), b) illicit opioid urine test results; (c) self-reported illicit opioid use; d) re-arrest and reincarceration; e) non-fatal and fatal overdose.
  • Explore barriers and facilitators to telemedicine XR-B implementation in jail: (1) telemedicine XR-B administration; (2) telemedicine staffing (both custody and medical); and (2) continuity of care after release to a community provider

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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).

Treatment and study plan

Extended Release Buprenorphine

Drug

extended-release buprenorphine using telemedicine in jail

Primary outcomes

  1. medication adherence

    Time frame: three months post-release

    number of extended-release buprenorphine injections completed

Secondary outcomes

  1. illicit opioid use

    Time frame: three months post-release

    Illicit opioid use days using the Timeline Follow-Back (TLFB)

  2. Urine toxicology

    Time frame: three months post-release

    urine toxicology rapid test for illicit opioids

  3. overdose

    Time frame: three months post-release

    Opioid Overdose times non-fatal

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Registry information

Official study title

An Open Label Pilot Study of Extended-release Buprenorphine (XR-B) Using Telemedicine With Individuals in Jail

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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