Addiction Science & Clinical Practice (Feb 2021)

Comparing rapid micro-induction and standard induction of buprenorphine/naloxone for treatment of opioid use disorder: protocol for an open-label, parallel-group, superiority, randomized controlled trial

  • James S. H. Wong,
  • Mohammadali Nikoo,
  • Jean N. Westenberg,
  • Janet G. Suen,
  • Jennifer Y. C. Wong,
  • Reinhard M. Krausz,
  • Christian G. Schütz,
  • Marc Vogel,
  • Jesse A. Sidhu,
  • Jessica Moe,
  • Shane Arishenkoff,
  • Donald Griesdale,
  • Nickie Mathew,
  • Pouya Azar

DOI
https://doi.org/10.1186/s13722-021-00220-2
Journal volume & issue
Vol. 16, no. 1
pp. 1 – 10

Abstract

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Abstract Background Buprenorphine/naloxone (Suboxone) is a current first-line treatment for opioid use disorder (OUD). The standard induction method of buprenorphine/naloxone requires patients to be abstinent from opioids and therefore experience withdrawal symptoms prior to induction, which can be a barrier in starting treatment. Rapid micro-induction (micro-dosing) involves the administration of small, frequent does of buprenorphine/naloxone 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 buprenorphine/naloxone in patients with OUD. Methods This is a randomized, open-label, two-arm, superiority, controlled trial comparing the safety and effectiveness of rapid micro-induction versus standard induction of buprenorphine/naloxone for the treatment of OUD. A total of 50 participants with OUD will be randomized at one Canadian hospital. The primary outcome is the completion of buprenorphine/naloxone induction with low levels of withdrawal. Secondary outcomes are treatment retention, illicit drug use, self-reported drug use behaviour, craving, pain, physical health, safety, and client satisfaction. Discussion This is the first randomized controlled trial to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone. This study will thereby generate evidence for a novel induction method which eliminates substantial barriers to the use of buprenorphine/naloxone in the midst of the ongoing opioid crisis. Trial registration ClinicalTrials.gov, NCT04234191; date of registration: January 21, 2020; https://clinicaltrials.gov/ct2/show/NCT04234191

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