Clinical trial NCT06306443: Buprenorphine for Individuals in Jail
Official title: A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Opioid Use Disorder
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

Detailed description: This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

Aim 1. Compare the effectiveness of XR-B vs. SL-B Aim 2. To calculate the cost to the state and/or jail/city health system of implementing XR-B and SL-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective.

Aim 3. Explore barriers and facilitators to XR-B versus SL-B implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily versus XR-B buprenorphine dosing; and (5) patient preference for XR-B versus SL-B.

Primary Outcome. (a) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use using Timeline Followback; and iii. time to opioid relapse).

Secondary Outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use using Timeline Followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration).

Costs. (a) cost to the correctional system; (b) costs associated with community intervention

Eligibility criteria: Inclusion Criteria:

* Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial \[note: individuals who might be sentenced to state/federal prison will be excluded\]); 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 and/or SL-B treatment as determined by medical evaluation;
* Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community;
* Planning to live in Baltimore City or the Baltimore Region;

Exclusion Criteria:

* Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion);
* 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 6 months);
* Inability to pass a study enrollment quiz; and
* Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone).

Primary outcomes:
measure: urine toxicology
timeFrame: 12-months
measure: days of opioid use
timeFrame: 12-months
measure: time to opioid relapse
timeFrame: 12-months
Secondary outcomes:
measure: retention in buprenorphine treatment
timeFrame: 6-months
measure: urine toxicology for other illicit substance use
timeFrame: 12-months
measure: days of illicit substance use
timeFrame: 12-months
measure: overdose events
timeFrame: 12-months
measure: PROMIS Patient-Reported Outcomes Measurement Information System - physical health
timeFrame: 12-months
measure: PROMIS Patient-Reported Outcomes Measurement Information System - mental health
timeFrame: 12-months
measure: HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score
timeFrame: 12-months
measure: HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score
timeFrame: 12-months
measure: criminal activity
timeFrame: 12-months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
city: Baltimore
country: United States
facility: Baltimore Central Booking & Intake Center
state: Maryland
Study officials:
References: