scholarly journals Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial

2019 ◽  
Vol 28 (1) ◽  
pp. e1768 ◽  
Author(s):  
Mohammadali Nikoo ◽  
Ehsan Moazen-Zadeh ◽  
Nooshin Nikoo ◽  
Sanam Javidanbardan ◽  
Alireza Kazemi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Double Blind ◽  
Medication Assisted Treatment ◽  
Randomized Controlled ◽  
Parallel Group

scholarly journals 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

2020 ◽  
Author(s):  
James S.H. Wong ◽  
Mohammadali Nikoo ◽  
Jean N. Westenberg ◽  
Janet G. Suen ◽  
Jennifer Wong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Use ◽  
Controlled Trial ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Induction Method ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Successful Induction

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 successful induction of buprenorphine/naloxone 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.

scholarly journals 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

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
James S. H. Wong ◽  
Mohammadali Nikoo ◽  
Jean N. Westenberg ◽  
Janet G. Suen ◽  
Jennifer Y. C. Wong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Use ◽  
Controlled Trial ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Induction Method ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Low Levels

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

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