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

Autor: 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
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Addiction Science & Clinical Practice, Vol 16, Iss 1, Pp 1-10 (2021)
Druh dokumentu: article
ISSN: 1940-0640
DOI: 10.1186/s13722-021-00220-2
Popis: 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
Databáze: Directory of Open Access Journals