Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

April 29, 2026 updated by: Friends Research Institute, Inc.

A Comparative Effectiveness Trial of Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a Type 1 hybrid effectiveness-implementation trial. County jails willing to provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) will participate in a randomized controlled trial throughout the state of Maryland, in which 240 incarcerated men and women will be randomly assigned within gender within jail to one of two arms: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a treatment program. Arm 2. XR-NTX (n=120). XR-NTX in jail, followed by 6 monthly injections post-release at a treatment program. In addition to the RCT the investigators will use a learning collaborative to examine the acceptability and feasibility of medications for opioid use disorder (MOUDs). Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received). Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional counties that selected not to participate in the randomized trial to understand factors related to: (a) acceptability of providing long-acting agonists and antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail to community treatment providers. Aim 3. Calculate the cost to the correctional health system of implementing an XR-B or XR-NTX program, and determine the relative value of each strategy, including the costs associated with the subsequent interventions in the community, from a state-policymaker and societal perspective.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Friends Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult male or female inmates at participating jails who are eligible for release within 120 days
  • 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 XR-NTX treatment as determined by medical evaluation
  • Willingness to enroll in XR-B or XR-NTX treatment in jail
  • Planning to live in one of the 7 participating counties and/or surrounding counties

Exclusion Criteria:

  • Liver function test levels greater than 4 times normal;
  • 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 naltrexone and/or buprenorphine;
  • Current chronic pain diagnosis for which opioids are prescribed;
  • Pregnancy (for women);
  • Breast-feeding (for women);
  • Suicidal ideation (within the past 6 months);
  • Body Mass Index (BMI) > 40;
  • Inability to pass a study enrollment quiz;
  • Currently enrolled in jail-based MOUD pharmacotherapy (methadone, buprenorphine, naltrexone)
  • Enrolled in a methadone treatment program in the past 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XR-B
Extended-release buprenorphine
Drug: XR-B
Individuals will receive extended-release buprenorphine, administered as a subcutaneous injection, is available in seven different dosage strengths for weekly (8, 16, 24, and 32 mg) and monthly (64, 96, and 128 mg) administration by a health care professional.
Other Names:
  • extended-release buprenorphine
Active Comparator: XR-NTX
Extended-release naltrexone
Drug: XR-NTX
Injectable naltrexone will be used, at a dose of 4cc (380mg of naltrexone), administered by intramuscular injection to the buttocks (alternating sides monthly). Individuals will receive monthly injections.
Other Names:
  • extended-release naltrexone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacotherapy adherence
Time Frame: 6-months post-release
number of monthly injections received (0-6)
6-months post-release

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
illicit opioid urine screening test results
Time Frame: 1-7,12-months
number of illicit opioid positive urine drug screen results
1-7,12-months
self-reported illicit opioid use
Time Frame: Baseline, 1-7,12-months
self reported days of illicit opioid use
Baseline, 1-7,12-months
overdose events
Time Frame: Baseline, 1-7,12-months
number of fatal and non-fatal overdoses
Baseline, 1-7,12-months
Patient-Reported Outcomes Measurement Information System
Time Frame: Baseline, 1-7,12-months

physical, mental, and social health

  • scored 0: Death
  • scored < 1: A state worse than perfect health
Baseline, 1-7,12-months
Risk Assessment Battery (RAB)
Time Frame: Baseline, 1-7,12-months
HIV risk behaviors; total score/40 (range=0-1)
Baseline, 1-7,12-months
Criminal activity
Time Frame: Baseline, 1-7,12-months
number of days committed crime (20 crimes)
Baseline, 1-7,12-months
Re-arrest
Time Frame: 12-months
time to rearrest (days to arrest)
12-months
Re-incarceration
Time Frame: 12-months
time to re-incarceration (days to re-incarceration)
12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friends Research Institute, Inc.

Investigators

  • Principal Investigator: Michael S Gordon, DPA, Friends Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1UG1DA050077 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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