TY - JOUR
T1 - Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder
T2 - Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial
AU - Nikoo, Mohammadali
AU - Moazen-Zadeh, Ehsan
AU - Nikoo, Nooshin
AU - Javidanbardan, Sanam
AU - Kazemi, Alireza
AU - Choi, Fiona
AU - Vogel, Marc
AU - Gholami, Ali
AU - Tavakoli, Saeed
AU - Givaki, Reza
AU - Jazani, Majid
AU - Mohammadian, Fatemeh
AU - Markazi Moghaddam, Nader
AU - Goudarzi, Nasser
AU - Schutz, Christian
AU - Jang, Kerry
AU - Akhondzadeh, Shahin
AU - Krausz, Michael
N1 - Publisher Copyright:
© 2019 John Wiley & Sons, Ltd.
PY - 2019/3
Y1 - 2019/3
N2 - Objectives: This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder. Methods: In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175). Results: To be reported after final analysis. Conclusions: If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.
AB - Objectives: This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder. Methods: In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175). Results: To be reported after final analysis. Conclusions: If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.
KW - clinical trial
KW - methadone
KW - opioid
KW - opium
KW - substance use
UR - http://www.scopus.com/inward/record.url?scp=85061036661&partnerID=8YFLogxK
U2 - 10.1002/mpr.1768
DO - 10.1002/mpr.1768
M3 - Article
C2 - 30714249
AN - SCOPUS:85061036661
SN - 1049-8931
VL - 28
JO - International Journal of Methods in Psychiatric Research
JF - International Journal of Methods in Psychiatric Research
IS - 1
M1 - e1768
ER -