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Active (not recruiting) Phase 3 NCT07524738

Telemedicine XR-B for Individuals in Jail

Phase 3 – large-scale trial before approval
Conditions: Opioid Use Disorder

Sponsor: Friends Research Institute, Inc.

trial.available_in: БГ
Overview
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
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. 2\) 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. 3\) 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
Inclusion Criteria: 1. 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; 2. 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); 3. Suitability for XR-B treatment as determined by medical evaluation; 4. Willingness to enroll in XR-B treatment in jail and continue in the community; Exclusion Criteria: 1. 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); 2. 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); 3. 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); 4. History of allergic reaction to buprenorphine; 5. Suicidal ideation (within the past 3 months); 6. Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone).
Interventions
Extended Release Buprenorphine
DRUG
Locations 1
United States (1)
Allegany County Detention Center
Cumberland , Maryland
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2025
Completion date
01.09.2026
Registry ID
NCT07524738
Source
clinicaltrials.gov
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