Abstract
BackgroundBuprenorphine/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.MethodsThis 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.DiscussionThis 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
Highlights
Buprenorphine/naloxone (Suboxone) is a current first-line treatment for opioid use disorder (OUD)
This study was initiated in response to the lack of research evaluating novel buprenorphine/naloxone induction protocols
While buprenorphine/naloxone has been widely accepted as a treatment method for OUD due to its superior safety profile compared to other opioid agonist treatment (OAT) options, there are still several barriers that have prevented its widespread use
Summary
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 experience withdrawal symptoms prior to induction, which can be a barrier in starting treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone in patients with OUD. Opioid-related deaths have surpassed motor vehicle incidents and homicide deaths combined, resulting in decreases in life expectancy in North America [1, 5]. These deaths are primarily driven by untreated opioid use disorder (OUD), a common disorder affecting millions of individuals worldwide [6]. OAT is associated with reducing mortality, illicit drug use, and improving physical and mental health outcomes [9]
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