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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 658 participants in total. It began in 2021-07-23 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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)
Contact & Investigator
Jessica Moe, MD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT04893525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04893525 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04893525 currently recruiting?
Yes, NCT04893525 is actively recruiting participants. Contact the research team at seth.long@ubc.ca for enrollment information.
Where is the NCT04893525 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Edmonton, Canada, Vancouver, Canada and 2 additional locations.
Who is sponsoring the NCT04893525 clinical trial?
NCT04893525 is sponsored by University of British Columbia. The principal investigator is Jessica Moe, MD at University of British Columbia. The trial plans to enroll 658 participants.