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Buprenorphine for Individuals in Jail

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jul 1, 2025 to Jun 20, 2025v5
  2. Primary completion pushed from Aug 31, 2028 to Jan 1, 2029
    • Study completion moved earlier from Dec 31, 2029 to Apr 30, 2029
    v4
  3. Trial status: Active, Not Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Aug 31, 2025 to Aug 31, 2028
    • Start date: Jun 1, 2023 to Jul 1, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2029
    • Site details revised at 2 of 2 sites
  4. Primary completion date: Dec 31, 2027 to Aug 31, 2025v2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2028 to Dec 31, 2025
    • Start date changed from estimate of Jun 1, 2024 to Jun 1, 2023
    • Site contacts updated at 1 of 2 sites
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.
Trial Details
NCT Number NCT06306443
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