Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    May 23, 2023
  • participants needed
    50
  • sponsor
    University of British Columbia
Updated on 23 October 2022

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.

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.

Details
Condition Opioid Use Disorder
Treatment Hydromorphone, Buprenorphine/naloxone
Clinical Study IdentifierNCT04234191
SponsorUniversity of British Columbia
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria
Individuals seeking Opioid Agonist Treatment (OAT)
Be 19 years of age or older
Be willing and able to adhere to the study protocol and follow-up schedule
Be able to provide written informed consent to participate in the clinical trial
If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study

Exclusion Criteria

Diagnosis of severe medical or psychiatric conditions contraindicated for buprenorphine/naloxone or hydromorphone treatment
Anticipated deterioration of health due to discontinuation of medications that are contraindicated with buprenorphine/naloxone and/or hydromorphone
Positive pregnancy test for women of childbearing potential
Methadone use in the past 5 days
Buprenorphine use in the past 5 days
Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone
Anticipation that the patient may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion
Unwilling or unable to use an effective method of birth control approved by the study investigators throughout the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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