Buprenorphine/naloxone Microdosing for Opioid Use Disorder

Royal Alexandra Hospital, Edmonton, Canada
Opioid Use DisorderBuprenorphine/naloxone - Drug
All Sexes

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.

Eligible Conditions
  • Opioid Use Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 30, 90, and 365 days

14 days
Number of patients who have filled a prescription for buprenorphine/naloxone within two weeks of their ED visit.
Day 365
Number of patients retained in Opioid agonist therapy (OAT) following the ED visit
Day 365
Number of fatal or non-fatal overdose events, mortality, ED visits, physician visits, admissions, and days admitted to hospital for patients following ED visit.

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
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.

Trial Design

2 Treatment Groups

Buprenorphine/naloxone Microdosing
1 of 2
Buprenorphine/naloxone Standard Dosing
1 of 2

Active Control

658 Total Participants · 2 Treatment Groups

Primary Treatment: Buprenorphine/naloxone Microdosing · No Placebo Group · Phase 2 & 3

Buprenorphine/naloxone Microdosing
ActiveComparator Group · 1 Intervention: Buprenorphine/naloxone · Intervention Types: Drug
Buprenorphine/naloxone Standard Dosing
ActiveComparator Group · 1 Intervention: Buprenorphine/naloxone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30, 90, and 365 days

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,354 Previous Clinical Trials
1,564,203 Total Patients Enrolled
Jessica Moe, MDPrincipal InvestigatorUniversity of British Columbia
Jessica MoePrincipal InvestigatorUniversity of British Columbia

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.