drugset / Trial / NCT04893525

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

NCT04893525

Phase 2/3 Recruiting 658 enrolled University of British Columbia
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-07-23
Primary completion
2026-12
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buprenorphine Other / unclassified 16 mg Subcutaneous
Comparator Naloxone Small molecule 3 mg Subcutaneous
Comparator Naloxone Small molecule 4 mg Subcutaneous