Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

NCT04408313 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 1UG1DA050077
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• pharmacotherapy adherence

  number of monthly injections received (0-6)

  6-months post-release

Secondary Outcomes (8)

• illicit opioid urine screening test results

  1-7,12-months

• self-reported illicit opioid use

  Baseline, 1-7,12-months

• overdose events

  Baseline, 1-7,12-months

• Patient-Reported Outcomes Measurement Information System

  Baseline, 1-7,12-months

• Risk Assessment Battery (RAB)

  Baseline, 1-7,12-months

Study Arms (2)

XR-B

EXPERIMENTAL

Extended-release buprenorphine

Drug: XR-B

XR-NTX

ACTIVE COMPARATOR

Extended-release naltrexone

Drug: XR-NTX

Interventions

XR-B DRUG

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.

Also known as: extended-release buprenorphine

XR-B

XR-NTX DRUG

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.

Also known as: extended-release naltrexone

XR-NTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead

Study Sites (1)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

  PMID: 40342086 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael S Gordon, DPA

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: October 28, 2020
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)