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: | Christian G. Schütz, Jessica Moe, Jean Nicolas Westenberg, Janet Suen, Jesse A. Sidhu, James S H Wong, Mohammadali Nikoo, Shane Arishenkoff, Nickie Mathew, Reinhard Michael Krausz, Donald E. G. Griesdale, Pouya Azar, Marc Vogel, Jennifer S. Wong |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
lcsh:Social pathology. Social and public welfare. Criminology
Buprenorphine/naloxone Craving lcsh:HV1-9960 law.invention 03 medical and health sciences Study Protocol 0302 clinical medicine Randomized controlled trial law Naloxone medicine 030212 general & internal medicine Protocol (science) lcsh:R5-920 business.industry Opioid use disorder General Medicine medicine.disease Opioid agonist treatment Microdosing Opioid Anesthesia Psychopharmacology medicine.symptom Open label lcsh:Medicine (General) business Micro-induction Suboxone 030217 neurology & neurosurgery Buprenorphine medicine.drug |
| Zdroj: | Addiction Science & Clinical Practice Addiction Science & Clinical Practice, Vol 16, Iss 1, Pp 1-10 (2021) |
| DOI: | 10.1101/2020.05.22.20106062 |
| Popis: | 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: | OpenAIRE |
| Externí odkaz: |
|