MedTrace Logo

Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

NCT04408313 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-05

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Friends Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Michael S Gordon, DPA · Friends Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2026-05-30
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408313 on ClinicalTrials.gov