Clinical Trial

Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

Active, Not Recruiting Phase 2/3
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Record status
This record was last updated May 5, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-05-26; most recent amendment 2026-04-29.
Status change: Recruiting → Active, Not Recruiting 2025-03-05
Status change: Not Yet Recruiting → Recruiting 2021-02-02
Trial Details
NCT Number NCT04408313
Lead Sponsor Friends Research Institute, Inc.
Conditions Opioid-use Disorder
Enrollment 240 participants
Start Date 2020-10-28
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-05