Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT04234191

Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

Led by University of British Columbia · Updated on 2024-06-11

50

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

V

Vancouver Coastal Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

The current first-line treatment for opioid use disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. Rapid micro-induction (also known as micro-dosing, low-dose induction) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with OUD.

CONDITIONS

Official Title

Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have opioid use disorder as defined by DSM-5 criteria
  • Seeking opioid agonist treatment
  • Be 19 years of age or older
  • Willing and able to follow the study protocol and schedule
  • Able to provide written informed consent
  • If female and able to have children, agree to use an approved birth control method during the study
Not Eligible

You will not qualify if you...

  • Have severe medical or psychiatric conditions that prevent use of buprenorphine/naloxone or hydromorphone
  • Anticipate health worsening from stopping medications that conflict with the study drugs
  • Positive pregnancy test if female and able to have children
  • Used methadone or buprenorphine in the past 5 days
  • Known allergy to buprenorphine/naloxone or hydromorphone
  • May need unsafe pharmacological treatment during the trial
  • Unwilling or unable to use approved birth control if female and able to have children

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

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Research Team

P

Pouya Azar, MD, FRCPC, DABAM

CONTACT

J

James Wong, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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