Comparing microdosing and standard dosing of buprenorphine/naloxone for opioid use disorder in emergency departments
Evaluating Microdosing in Emergency Departments: A Randomized Controlled Trial Comparing the Effectiveness of Buprenorphine/Naloxone Microdosing vs. Standard Dosing (EMED Study)
This study is testing whether a smaller dose of buprenorphine/naloxone can help adults with opioid use disorder start and stick with their treatment better than the usual dose when they come to the emergency department.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 658 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT04893525 on ClinicalTrials.gov |
What this trial studies
This multi-center, open-label randomized controlled trial evaluates the effectiveness of buprenorphine/naloxone microdosing versus standard dosing in emergency departments across British Columbia and Alberta. Patients aged 18 and older with opioid use disorder will be randomized to receive either a microdosing or standard dosing regimen of buprenorphine/naloxone. The study aims to determine which approach better enables patients to complete the induction period and remain in opioid agonist therapy over time. The primary outcome is the successful filling of a prescription for buprenorphine/naloxone within two weeks of the emergency department visit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with opioid use disorder who are being discharged from the emergency department and have a Clinical Opiate Withdrawal Score of 12 or lower.
Not a fit: Patients experiencing active withdrawal at the time of assessment or those admitted to the hospital will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the induction process for patients with opioid use disorder, leading to better retention in treatment and reduced overdose risk.
How similar studies have performed: Other studies have shown promise with microdosing approaches in opioid treatment, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Calgary, Alberta and 5 other locations
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- Northeast Community Health Centre — Edmonton, Alberta, Canada (Recruiting)
- Royal Alexandra Hospital — Edmonton, Alberta, Canada (Not_yet_recruiting)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
- University of British Columbia Hospital — Vancouver, British Columbia, Canada (Recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Jessica Moe, MD — University of British Columbia
- Study coordinator: Elle Wang, MSc
- Email: seth.long@ubc.ca
- Phone: 6046152538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.