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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30, 90, and 365 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients who have filled a prescription for buprenorphine/naloxone within two weeks of their ED visit.

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met