Telemedicine XR-B for Individuals in Jail (NCT07524738) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
Telemedicine XR-B for Individuals in Jail
United States30 participantsStarted 2025-06-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. 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;
ā. 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);
ā. Suitability for XR-B treatment as determined by medical evaluation;
ā. Willingness to enroll in XR-B treatment in jail and continue in the community;
Exclusion criteria
ā. 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);
ā. 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);
ā. 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);