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.

Affiliation

Wong JSH(1), Nikoo M(2), Westenberg JN(2), Suen JG(2), Wong JYC(2), Krausz RM(2), Schütz CG(3), Vogel M(4), Sidhu JA(5), Moe J(6)(7), Arishenkoff S(8), Griesdale D(9), Mathew N(#)(5)(10), Azar P(#)(5).
Author information:
(1)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. [Email]
(2)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.
(3)Behavioral Reward Affect + Impulsivity Neuroscience Lab, Institute of Mental Health, Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.
(4)Division of Addictive Disorders, University of Basel Psychiatric Hospital, Wilhelm Klein-Strasse 27, 4002, Basel, Switzerland.
(5)Department of Psychiatry, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.
(6)Department of Emergency Medicine, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.
(7)BC Centre for Disease Control, Provincial Health Services Authority, Vancouver, BC, Canada.
(8)Department of Medicine, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.
(9)Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.
(10)BC Mental Health & Substance Use Services, Provincial Health Services Authority, Vancouver, BC, Canada.
(#)Contributed equally

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.