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Opioid Use DisorderPhase 3NCT07524738

Telemedicine XR-B for Individuals in Jail

A Phase 3 study testing Extended Release Buprenorphine in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use Disorder
What is being tested?
Extended Release Buprenorphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Jun 2025to 1 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Allegany County Detention Center

    Cumberland, Maryland, 21502

Other trials in United States

About this study

Official title: An Open Label Pilot Study of Extended-release Buprenorphine (XR-B) Using Telemedicine With 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

Read the detailed description

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.

  1. 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.
  2. 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
Being tested
Extended Release Buprenorphine
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended Release BuprenorphineDrug

    extended-release buprenorphine using telemedicine in jail

Study groups in NCT07524738
Study groupRoleWhat they receive
XR-BExperimentalextended-release buprenorphine
Receives: Drug: Extended Release Buprenorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. medication adherence

    number of extended-release buprenorphine injections completed

    Measured: three months post-release

Secondary outcomes (3)
  1. illicit opioid use

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

    Measured: three months post-release

  2. Urine toxicology

    urine toxicology rapid test for illicit opioids

    Measured: three months post-release

  3. overdose

    Opioid Overdose times non-fatal

    Measured: three months post-release

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start1 Jun 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
extended-release buprenorphine
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524738
Sponsor's protocol ID
Telemed XR-B
Status last verified
Apr 2026
First submitted
6 Apr 2026
Last updated
24 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Need additional information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Extended Release Buprenorphine in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

medication adherence (time frame: three months post-release). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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