Buprenorphine for Individuals in Jail

Opioid Use Disorder Clinical Trial

Official title:

A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306443
• Other study ID #: 20235453
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Friends Research Institute, Inc.
• Contact: Michael Gordon, DPA
• Phone: 4108373977
• Email: mgordon[@]friendsresearch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Drug:
• extended-release buprenorphine (XR-B)
buprenorphine

Locations

Country	Name	City	State
United States	Baltimore Central Booking & Intake Center	Baltimore	Maryland
United States	Friends Research Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine toxicology	positive urine drug screen for opioids	12-months
Primary	days of opioid use	Number of days since last assessment	12-months
Primary	time to opioid relapse	days from release from jail to first relapse event	12-months
Secondary	retention in buprenorphine treatment	days receiving buprenorphine	6-months
Secondary	urine toxicology for other illicit substance use	positive urine drug screen	12-months
Secondary	days of illicit substance use	number of days since last assessment	12-months
Secondary	overdose events	fatal and non-fatal overdose events	12-months
Secondary	PROMIS Patient-Reported Outcomes Measurement Information System - physical health	Global physical health score	12-months
Secondary	PROMIS Patient-Reported Outcomes Measurement Information System - mental health	Global mental health score	12-months
Secondary	HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score	sexual risk behavior; Scored 0-18 (higher risk)	12-months
Secondary	HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score	needle use or sharing; Scored 0-22 (higher risk)	12-months
Secondary	criminal activity	i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration	12-months