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Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from University of British Columbia

Record History

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  1. Primary completion pushed from Dec 2026 to Dec 2027 Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from Jun 2027 to Jun 2028
    • Interventions: Buprenorphine/naloxone (Drug) to Buprenorphine/naloxone (Drug)
    • Eligibility criteria expanded, about 21 words
    • Site details revised at 1 of 6 sites
    • Publications: details revised at 3 of 3 entries
  2. Primary completion date: Dec 2024 to Dec 2026
    • Study completion date: Jun 2025 to Jun 2027
    v6
  3. Study sites: 4 to 6v5
  4. Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 1 of 4 sites
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2021 to Jul 23, 2021
    • Site details revised at 4 of 4 sites
    v3
  6. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study description expanded, about 17 words
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multi-centre, open-label RCT at four Emergency Departments (EDs) in British Columbia and Alberta. The purpose of the current study is to compare the effectiveness of buprenorphine/naloxone microdosing and standard dosing take-home induction regimens at enabling patients to successfully complete the induction regimen, and at retaining patients on opioid agonist therapy. We will randomize our enrolled patients to receive take-home microdosing or standard dosing packages of buprenorphine/naloxone. For the microdosing arm, patients immediately start taking low doses that increase to effective levels without requiring them to go into withdrawal. We hypothesize that ED patients provided buprenorphine/naloxone microdosing packages will be more likely to successfully complete the induction period compare to patients provided standard dosing packages. We furthermore hypothesize that those provided microdosing will be more likely to be retained in opioid agonist therapy, and will experience lower overdose, mortality, and healthcare utilization subsequent to their ED visit.
Trial Details
NCT Number NCT04893525
Lead Sponsor University of British Columbia
Conditions
(from sponsor)		 Opioid-use Disorder
Related terms Opioid-Related Disorders
Enrollment 658 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov