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

Last updated: June 10, 2024
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

2

Condition

Opioid Use Disorder

Stimulant Use Disorder

Treatment

Hydromorphone

Buprenorphine/naloxone

Clinical Study ID

NCT04234191
H19-03254
  • Ages > 19
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual ofMental Disorders-5 diagnostic criteria;

  2. Individuals seeking Opioid Agonist Treatment (OAT);

  3. Be 19 years of age or older;

  4. Be willing and able to adhere to the study protocol and follow-up schedule;

  5. Be able to provide written informed consent to participate in the clinical trial.

  6. If female and of childbearing potential, agree to use an effective method of birthcontrol approved by the study investigators throughout the study.

Exclusion

Exclusion Criteria:

  1. Diagnosis of severe medical or psychiatric conditions contraindicated forbuprenorphine/naloxone or hydromorphone treatment;

  2. Anticipated deterioration of health due to discontinuation of medications that arecontraindicated with buprenorphine/naloxone and/or hydromorphone;

  3. Positive pregnancy test for women of childbearing potential;

  4. Methadone use in the past 5 days;

  5. Buprenorphine use in the past 5 days;

  6. Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;

  7. Anticipation that the patient may need to initiate pharmacological treatment duringthe trial that is deemed unsafe by the study physician or could prevent studycompletion;

  8. Unwilling or unable to use an effective method of birth control approved by thestudy investigators throughout the study.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Hydromorphone
Phase: 2
Study Start date:
August 18, 2021
Estimated Completion Date:
January 31, 2025

Study Description

This is a randomized, controlled, open-label superiority trial involving 50 individuals with OUD. Participants will be randomized into two arms: rapid micro-induction and standard induction (based on the American Society of Addiction Medicine Practice Guidelines and product monograph) of bup/nx.

Connect with a study center

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

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