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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30, 90, and 365 days

Awards & highlights

Study 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

Select...

I am over 18 and have an opioid use disorder, being discharged from the ED.

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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,358 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions does Buprenorphine/naloxone Microdosing help alleviate?

"Buprenorphine/naloxone Microdosing is a medication used to treat opioids most often, but it can also serve as relief for conditions such as pruritus, pain, and septic shock."

Answered by AI

Are there any other instances where Buprenorphine/naloxone have been microdosed for research purposes?

"At the moment, 60 clinical trials are researching Buprenorphine/naloxone Microdosing. 14 of these trials are in Phase 3. While most of the studies for Buprenorphine/naloxone Microdosing are located in White River Junction, Vermont, there are 243 locations operating studies for Buprenorphine/naloxone Microdosing."

Answered by AI