Author/Authors :
Wong, James S. H. Addictions and Concurrent Disorders Research Group - Institute of Mental Health - Department of Psychiatry, The University of British Columbia, Vancouver, Canada , Nikoo, Mohammadali Addictions and Concurrent Disorders Research Group - Institute of Mental Health - Department of Psychiatry, The University of British Columbia, Vancouver, Canada , Westenberg, Jean N. Addictions and Concurrent Disorders Research Group - Institute of Mental Health - Department of Psychiatry, The University of British Columbia, Vancouver, Canada , Suen, Janet G. Addictions and Concurrent Disorders Research Group - Institute of Mental Health - Department of Psychiatry, The University of British Columbia, Vancouver, Canada , Wong, Jennifer Y. C. Addictions and Concurrent Disorders Research Group - Institute of Mental Health - Department of Psychiatry, The University of British Columbia, Vancouver, Canada , Krausz, Reinhard M. Addictions and Concurrent Disorders Research Group - Institute of Mental Health - Department of Psychiatry, The University of British Columbia, Vancouver, Canada , Schütz, Christian G. Behavioral Reward Affect + Impulsivity Neuroscience Lab - Institute of Mental Health - Department of Psychiatry - University of British Columbia, Vancouver, BC Canada , Vogel, Marc Division of Addictive Disorders - University of Basel Psychiatric Hospital, Basel, Switzerland , Sidhu, Jesse A. Department of Psychiatry - University of British Columbia & Vancouver General Hospital, Vancouver, BC Canada , Moe, Jessica Department of Emergency Medicine - University of British Columbia & Vancouver General Hospital, Vancouver, BC Canada , Arishenkoff, Shane Department of Medicine - University of British Columbia & Vancouver General Hospital, Vancouver, BC Canada , Griesdale, Donald Department of Anesthesiology - Pharmacology and Therapeutics - University of British Columbia & Vancouver General Hospital, Vancouver, BC Canada , Mathew, Nickie Department of Psychiatry - University of British Columbia & Vancouver General Hospital, Vancouver, BC Canada , Azar, Pouya Department of Psychiatry - University of British Columbia & Vancouver General Hospital, Vancouver, BC Canada
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.
