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Opioid Agonist

Buprenorphine/Naloxone Dosing Strategies for Opioid Use Disorder

Phase 2 & 3
Recruiting
Led By Jessica Moe
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ED patients ≥18 years of age with opioid use disorder who are being discharged from the ED
Be older than 18 years old
Must not have
Active prescription for sedative medications
Known or suspected mechanical gastrointestinal obstruction or conditions affecting bowel transit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 90, and 365 days
Awards & highlights

Summary

This trial will compare the effectiveness of two different regimens for taking buprenorphine/naloxone to treat opioid addiction. One group will take increasing doses of the medication until they reach an effective level, while the other group will take a standard dose.

Who is the study for?
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.Check my eligibility
What is being tested?
The study compares two methods of starting buprenorphine/naloxone treatment for opioid addiction: microdosing without withdrawal symptoms versus standard dosing. Patients leaving emergency departments will receive either method to see which is more effective at keeping them on treatment.See study design
What are the potential side effects?
Buprenorphine/naloxone can cause side effects like nausea, vomiting, drug withdrawal syndrome, headaches, sweating, numb mouth, constipation, painful tongue and redness in the mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and have an opioid use disorder, being discharged from the ED.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently prescribed sedatives.
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I have or might have a blockage in my intestines.
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I have severe difficulty breathing.
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I haven't taken monoamine oxidase inhibitors in the last 14 days.
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I might need surgery for my abdominal issue.
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I am allergic to buprenorphine/naloxone.
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I do not have severe breathing or liver problems.
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I am taking opioids for cancer-related pain.
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I do not have severe brain issues like high pressure or recent head injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30, 90, and 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 90, and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients who have filled a prescription for buprenorphine/naloxone within two weeks of their ED visit.
Secondary outcome measures
Number of fatal or non-fatal overdose events, mortality, ED visits, physician visits, admissions, and days admitted to hospital for patients following ED visit.
Number of patients retained in Opioid agonist therapy (OAT) following the ED visit

Trial Design

2Treatment groups
Active Control
Group I: Buprenorphine/naloxone Standard DosingActive Control1 Intervention
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).
Group II: Buprenorphine/naloxone MicrodosingActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,431 Previous Clinical Trials
2,478,245 Total Patients Enrolled
Jessica MoePrincipal InvestigatorUniversity of British Columbia
Jessica Moe, MDPrincipal InvestigatorUniversity of British Columbia

Media Library

Buprenorphine/naloxone (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04893525 — Phase 2 & 3
Opioid Use Disorder Research Study Groups: Buprenorphine/naloxone Standard Dosing, Buprenorphine/naloxone Microdosing
Opioid Use Disorder Clinical Trial 2023: Buprenorphine/naloxone Highlights & Side Effects. Trial Name: NCT04893525 — Phase 2 & 3
Buprenorphine/naloxone (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893525 — Phase 2 & 3
~66 spots leftby Dec 2024
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