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Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date: Jun 30, 2025 to May 30, 2026
    • Study completion date: Dec 31, 2025 to May 31, 2026
    v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  4. Site contact updatedv8
  5. Primary completion date: Aug 31, 2023 to Jun 30, 2025
    • Study completion date: Jan 2, 2025 to Dec 31, 2025
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jul 1, 2024 to Aug 31, 2023
    • Study completion date: Dec 31, 2024 to Jan 2, 2025
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: Apr 30, 2023 to Jul 1, 2024
    • Study completion date: Apr 30, 2024 to Dec 31, 2024
    • Start date: Oct 15, 2020 to Oct 28, 2020
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2020 to Oct 15, 2020
    v3
  5. Start date: Jul 1, 2020 to Aug 2020
    • Eligibility criteria shortened, about 17 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04408313
Lead Sponsor Friends Research Institute, Inc.
Conditions
(from sponsor)		 Opioid-use Disorder
Related terms Opioid-Related Disorders
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov