Buprenorphine/Naloxone Dosing Strategies for Opioid Use Disorder
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but if you are actively receiving opioid agonist therapy or have an active prescription for sedative medications, you may not be eligible to participate.
What data supports the effectiveness of the drug buprenorphine/naloxone for opioid use disorder?
Buprenorphine/naloxone is shown to improve outcomes for people seeking treatment for opioid use disorder, although its effectiveness can be limited by low adherence to the medication, especially early in treatment. Additionally, micro-dosing strategies may help overcome challenges related to starting the medication.12345
Is Buprenorphine/Naloxone safe for humans?
Buprenorphine/naloxone is generally considered safe for treating opioid use disorder and chronic pain, with mild and rare adverse effects due to the naloxone component. It has been used safely in clinical settings, although some concerns about side effects and patient-provider relationships have been noted.46789
How is the drug buprenorphine/naloxone unique for treating opioid use disorder?
Buprenorphine/naloxone is unique because it combines buprenorphine, which helps reduce cravings and withdrawal symptoms, with naloxone, which discourages misuse by blocking opioid effects if injected. This combination is available in a sublingual (under the tongue) tablet form, offering flexibility in dosing schedules and reducing the risk of abuse compared to other treatments.1351011
Research Team
Jessica Moe, MD
Principal Investigator
University of British Columbia
Eligibility Criteria
This trial is for adults over 18 in British Columbia or Alberta with opioid use disorder, who have used opioids non-medically in the past month and are not currently hospitalized. They must score positively on a dependency screen but not be in active withdrawal or receiving opioid therapy recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive a five-day take-home package of buprenorphine/naloxone, either microdosing or standard dosing, to initiate opioid agonist therapy.
Follow-up
Participants are monitored for retention on opioid agonist therapy and healthcare utilization, including overdose and mortality, at 30, 90, and 365 days.
Treatment Details
Interventions
- Buprenorphine/naloxone
Buprenorphine/naloxone is already approved in European Union, United States, Canada for the following indications:
- Opioid dependence
- Opioid use disorder
- Opioid dependence
- Opioid use disorder
- Opioid dependence
- Opioid use disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor