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Addict Sci Clin Pract · 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, and Pouya Azar.
- Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Department of Psychiatry, The University of British Columbia, 430-5950, David Strangway Building, Vancouver, BC, V6T 1Z3, Canada. james.wong@ubc.ca.
- Addict Sci Clin Pract. 2021 Feb 12; 16 (1): 11.
BackgroundBuprenorphine/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.MethodsThis 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.DiscussionThis 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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