NCT04893525 Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments
| NCT ID | NCT04893525 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of British Columbia |
| Condition | Opioid-use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 658 participants |
| Start Date | 2021-07-23 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: We will include ED patients ≥18 years of age with opioid use disorder who are being discharged from the ED. We will define opioid use disorder as non-medical opioid use in the previous 30 days and a positive score for opioid dependency based on the validated Rapid Opioid Dependence Screen (RODS). All patients will also be assessed by the treating physician or degree of clinical opioid withdrawal, based on the clinical opiate withdrawal scale (COWS) score. Patients will be eligible for the take-home study interventions if they have a COWS score \<=12, as a score greater than 12 would mean the patient is a candidate for standard buprenorphine induction in the ED at that moment in time, and would therefore not be eligible for outpatient study interventions. Exclusion Criteria: * Active withdrawal at time of ED assessment (Clinical Opiate Withdrawal Score \[COWS\] \>12) * Admitted to hospital * Severe communication barriers that inhibit patients' understanding of study