Clinical Trial

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

Recruiting Phase 2/3
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-05-14; most recent amendment 2025-06-04.
Status change: Not Yet Recruiting → Recruiting 2021-07-30
Trial Details
NCT Number NCT04893525
Lead Sponsor University of British Columbia
Conditions Opioid-use Disorder
Enrollment 658 participants
Start Date 2021-07-23
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-06-08