Nickie Mathew1,2, Pouya Azar1, James S H Wong3, Mohammadali Nikoo4, Jean N Westenberg4, Janet G Suen4, Jennifer Y C Wong4, Reinhard M Krausz4, Christian G Schütz5, Marc Vogel6, Jesse A Sidhu1, Jessica Moe7,8, Shane Arishenkoff9, Donald Griesdale10. 1. Department of Psychiatry, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada. 2. BC Mental Health & Substance Use Services, Provincial Health Services Authority, Vancouver, BC, Canada. 3. 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. 4. 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. 5. Behavioral Reward Affect + Impulsivity Neuroscience Lab, Institute of Mental Health, Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada. 6. Division of Addictive Disorders, University of Basel Psychiatric Hospital, Wilhelm Klein-Strasse 27, 4002, Basel, Switzerland. 7. Department of Emergency Medicine, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada. 8. BC Centre for Disease Control, Provincial Health Services Authority, Vancouver, BC, Canada. 9. Department of Medicine, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada. 10. Department of Anesthesiology, Pharmacology and Therapeutics, 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. Trial registration ClinicalTrials.gov, NCT04234191; date of registration: January 21, 2020; https://clinicaltrials.gov/ct2/show/NCT04234191.
RCT Entities:
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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