Opioid Use Disorder
Conditions
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
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. 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
Interventions
extended-release buprenorphine using telemedicine in jail
Sponsors
Friends Research Institute, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
extended-release buprenorphine
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| medication adherence | three months post-release | number of extended-release buprenorphine injections completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| illicit opioid use | three months post-release | Illicit opioid use days using the Timeline Follow-Back (TLFB) |
| Urine toxicology | three months post-release | urine toxicology rapid test for illicit opioids |
| overdose | three months post-release | Opioid Overdose times non-fatal |
Countries
United States
Outcome results
None listed