Buprenorphine for Individuals in Jail

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Drug: extended-release buprenorphine (XR-B)

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

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Michael Gordon, DPA; Phone Number: 251 4108373977; Email: mgordon@friendsresearch.org
• Study Contact Backup: Name: Thomas R Blue, PhD; Phone Number: 4108373977; Email: tblue@friendsresearch.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Friends Research Institute
      • Contact: Michael Gordon; Phone Number: 4108373977; Email: mgordon@friendsresearch.org
    • Baltimore, Maryland, United States, 21202
      • Recruiting
      • Baltimore Central Booking & Intake Center
      • Contact: Michael Gordon, DPA; Phone Number: 251 4108373977; Email: mgordon@friendsresearch.org
      • Contact: Thomas R Blue, PhD; Phone Number: 4108373977; Email: tblue@friendsresearch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: extended-release buprenorphine (XR-B); Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.	Drug: extended-release buprenorphine (XR-B); buprenorphine; Other Names: sublingual buprenorphine (SL-B)
Active Comparator: sublingual buprenorphine (SL-B); Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone.	Drug: extended-release buprenorphine (XR-B); buprenorphine; Other Names: sublingual buprenorphine (SL-B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine toxicology	positive urine drug screen for opioids	12-months
days of opioid use	Number of days since last assessment	12-months
time to opioid relapse	days from release from jail to first relapse event	12-months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 20235453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Working on a plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No