Actively Recruiting
Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments
Led by University of British Columbia · Updated on 2025-06-08
658
Participants Needed
6
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with opioid use disorder being discharged from the ED
- Opioid use disorder defined as non-medical opioid use in the past 30 days and positive opioid dependency score on the Rapid Opioid Dependence Screen (RODS)
- Clinical Opiate Withdrawal Scale (COWS) score less than or equal to 12 at ED assessment
- Patients must be able to understand study procedures and interventions
You will not qualify if you...
- Active withdrawal at time of ED assessment with COWS score greater than 12
- Hospital admission
- Severe communication barriers preventing understanding of study procedures
- Use of opioids for cancer or palliative care
- Deemed unsafe to approach by ED providers
- Incarceration
- Not a resident of the province (British Columbia or Alberta) where care is sought
- Currently receiving opioid agonist therapy with a prescription filled within 5 days before ED visit
- Prior enrollment in the study
- Known or suspected mechanical gastrointestinal obstruction or diseases affecting bowel transit
- Suspected surgical abdomen
- Severe respiratory insufficiency
- Severe central nervous system depression, increased intracranial pressure, or head injury
- Factors making home induction unsafe or requiring expert consultation, including allergy to buprenorphine/naloxone, severe respiratory or liver dysfunction, concurrent withdrawal or intoxication from sedatives, active prescription for sedative medications, use of monoamine oxidase inhibitors within 14 days, inability to safely store medications
- Pregnancy (confirmed by urine pregnancy test in women of child-bearing age)
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Trial Site Locations
Total: 6 locations
1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9
Actively Recruiting
2
Northeast Community Health Centre
Edmonton, Alberta, Canada, T5A 5E4
Actively Recruiting
3
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Not Yet Recruiting
4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
5
University of British Columbia Hospital
Vancouver, British Columbia, Canada, V6T2B5
Actively Recruiting
6
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
Research Team
E
Elle Wang, MSc
CONTACT
C
Cindy Liu, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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