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ACTIVE NOT RECRUITING
NCT04408313
PHASE2/PHASE3

Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

Sponsor: Friends Research Institute, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2020-10-28

Completion Date

2026-05-31

Last Updated

2026-01-26

Healthy Volunteers

No

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.

Locations (1)

Friends Research Institute

Baltimore, Maryland, United States