Status:
RECRUITING
Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments
Lead Sponsor:
University of British Columbia
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 m...
Detailed Description
This multi-centered, open-label RCT will be carried out at four emergency departments (EDs) across Canada, two in British Columbia (Vancouver General Hospital and St. Paul's Hospital) and two in Alber...
Eligibility Criteria
Inclusion
- 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
- 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 procedures and interventions
- Are taking opioids for cancer or palliative-care related indications
- Are deemed unsafe to approach by ED providers
- Incarceration
- Not a resident of the province in which they are seeking care (BC or Alberta)
- Actively receiving OAT, defined as having filled a prescription for one of the following medications in the 5 days prior to ED presentation: buprenorphine/naloxone, methadone, sustained release morphine, injectable hydromorphone, injectable diacetylmorphine
- Prior enrollment in the study
- Known or suspected mechanical gastrointestinal obstruction (e.g., bowel obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any type).
- Suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
- Severe respiratory insufficiency.
- Severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
- Complicating patient factors that make home inductions from the ED unsafe and/or that require expert consultation for consideration of induction in an observed setting.
- These factors include:
- Allergy to buprenorphine/naloxone
- Severe respiratory or liver dysfunction
- Concurrent withdrawal or intoxication from sedatives (e.g., alcohol, benzodiazepines)
- Active prescription for sedative medications (e.g., benzodiazepines, opioids)
- Use of monoamine oxidase inhibitors within the past 14 days
- Concerns that the patient is unable to safely store medications
- Pregnancy (we will obtain a point-of-care urine pregnancy test on all women of child-bearing age prior to enrollment)
Key Trial Info
Start Date :
July 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT04893525
Start Date
July 23 2021
End Date
June 1 2027
Last Update
June 8 2025
Active Locations (6)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9
2
Northeast Community Health Centre
Edmonton, Alberta, Canada, T5A 5E4
3
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9