Recruiting
Phase 2
Phase 3

Buprenorphine/Naloxone vs. Standard Dosing

Sponsor:

University of British Columbia

Code:

NCT04893525

Conditions

Opioid-use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine/naloxone

Study Details

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.

Conditions

Opioid-use Disorder

Study ID

NCT04893525

Start date

Jul 23, 2021

Status verified date

May, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

658 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Buprenorphine/naloxone Microdosing

Participants with Opioid use disorder will receive a Buprenorphine/naloxone microdosing package from the ED. This will consist of a five-day take-home packages with gradually increasing doses of 2mg/0.5mg buprenorphine/naloxone tablet employing a four times daily dosing schedule over five days.

Day 1: Buprenorphine 0.5 mg-naloxone 0.125 mg SL\* QID\*\* (One quarter tablet),

Day 2: Buprenorphine 1 mg-naloxone 0.25 mg SL QID (One half tablet),

Day 3: Buprenorphine 2 mg-naloxone 0.5 mg SL QID (1 tablet),

Day 4: Buprenorphine 3 mg-naloxone 0.75 mg SL QID (1.5 tablets)

Day 5: Buprenorphine 16 mg-naloxone 4 mg SL once daily (8 tablets).

\*SL: Sublingual

\*\* QID: four times daily

active comparator: Buprenorphine/naloxone Standard Dosing

The control intervention will be provision of a buprenorphine/naloxone standard dosing package from the ED. This will consist of a five day package with a commonly accepted standard dosing regimen aiming to achieve a therapeutic buprenorphine/naloxone dose within 24 hours of initiation. Standard dosing packages are currently available in EDs in BC and Alberta as standard of care.

Day 1: Buprenorphine 2 mg-naloxone 0.5 mg SL q1h prn to a maximum of 6 tablets in the first 24 hours (1 tablet),

Day 2: Buprenorphine 12 mg-naloxone 3 mg SL once daily (6 tablets),

Day 3: Buprenorphine 16 mg-naloxone 3 mg SL once daily (8 tablets),

Day 4:Buprenorphine 16 mg-naloxone 3 mg SL once daily (8 tablets).

Day 5:Buprenorphine 16 mg-naloxone 3 mg SL once daily (8 tablets).

Interventions

Buprenorphine/naloxone

Buprenorphine/naloxone is a first line, evidence-based opioid agonist therapy that improves mortality for people with opioid use disorder, and that has been demonstrated to be effective at retaining people in addictions care and decreasing illicit opioid use when initiated from EDs.

Primary outcome measure

  • Number of patients who have filled a prescription for buprenorphine/naloxone within two weeks of their ED visit. [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Elle Wang, MSc

6046152538seth.long@ubc.ca

Cindy Liu, BSc

778-929-1281elle.wang@ubc.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N2T9

Contacts

Kathryn Crowder, MD

4035619955Kathryn.Crowder@albertahealthservices.ca

Principal Investigator:

Kathryn Crowder, MD

Northeast Community Health Centre

Recruiting

Edmonton, Alberta, Canada, T5A 5E4

Contacts

Robert Wittmeier, MD

Robert.Wittmeier@albertahealthservices.ca

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Jessica Moe, MD

jessica.moe@ubc.ca

Principal Investigator:

Jessica Moe, MD

University of British Columbia Hospital

Recruiting

Vancouver, British Columbia, Canada, V6T2B5

Contacts

Jessica Moe, MD

2369826805jessica.moe@ubc.ca

Principal Investigator:

Jessica Moe, MD

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Andrew Kestler, MD

andrew.kestler@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jun 8, 2025

Last verified

May, 2025

Keywords

  • Buprenorphine/naloxone
  • Suboxone
  • Opioid agonist treatment
  • Micro-induction
  • Microdosing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-06-08.