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Opium tincture for opioid substitution treatment

Published online by Cambridge University Press:  13 August 2021

M. Nikoo ,
K. Kianpoor ,
N. Nikoo ,
S. Javidanbardan ,
A. Kazemi ,
F. Choi ,
M. Vogel ,
A. Gholami ,
S. Tavakoli  and
J. Wong
...Show all authors
M. Nikoo*
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
K. Kianpoor
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
N. Nikoo
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
S. Javidanbardan
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
A. Kazemi
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
F. Choi
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
M. Vogel
Affiliation:
Division Of Substance Use Disorders, Psychiatric Services of Thurgovia, Thurgovia, Switzerland
A. Gholami
Affiliation:
Substance Use Disorder, Kian Methadone Maintenance Treatment Clinic, Sari, Iran
S. Tavakoli
Affiliation:
Private Practice, Rooz-e-No, Methadone Maintenance Treatment Clinic, Shiraz, Iran
J. Wong
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
E. Moazen‐Zadeh
Affiliation:
Department Of Psychiatry, Addiction Institute of Mount Sinai, New York, United States of America
R. Givaki
Affiliation:
Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
M. Jazani
Affiliation:
Vice President Of Sales, Marketing, Export & Medical Department, Darou Pakhsh Pharmaceutical Mfg.Co., Tehran, Iran
F. Mohammadian
Affiliation:
Pharmacovigilance & Clinical Trial Manager, Darou Pakhsh Pharmaceutical Mfg Co., Tehran, Iran
N. Markazi Moghaddam
Affiliation:
Department Of Health Management And Economics, School of Medicine, AJA University of Medical Sciences, Tehran, Iran
C. Schütz
Affiliation:
Psychiatry, Institute of Mental Health, Vancouver, Canada
K. Jang
Affiliation:
Psychiatry, Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Vancouver, Canada
S. Akhondzadeh
Affiliation:
Psychiatric Research Center, Roozbeh Hospital, Department Of Psychiatry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
*
*Corresponding author.

Abstract

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Introduction

Opium tincture (OT) is widely used for opioid substitution treatment (OST) in Iran.

Objectives

To determine if OT is a safe and effective medication for OST.

Methods

Opium Trial was a multicenter, double‐blind, noninferiority randomized controlled trial, with 204 participants with opioid dependence in Iran. Participants were then randomized to OT or methadone arms with an allocation ratio of 1:1 and were followed for 12 weeks. The primary outcome was retention in treatment, compared between the two groups using both intention-To-Treat (ITT) and Per-Protocol (PP) analyses.

Results

A total of 70 participants (IT: 68.6%, PP: 69.3%) in methadone arm and 61 participants (ITT: 59.8%, PP: 60.4%) in OT arm remained in the treatment. The relative retention rate was 1.15 (0.97, 1.36) in both analyses in favour of methadone. A total of 46 out of 152 (30.3%) participants in OT arm and 83 out of 168 (49.4%) participants in methadone arm reported opioid use outside the treatment. The difference in these two proportions (OT - methadone) was 19%: (10%, 28%) in favour of OT. The proportion of patients with adverse events were not different between the two arms (P = 0.06). There was no serious AE in OT arm.

Conclusions

Opium tincture is a clinically effective and safe medication, but this study could not conclude if it was as equally effective as methadone in retaining participants in treatment, but it showed that OT was superior to methadone in reducing opioid use outside the treatment.

Disclosure

No significant relationships.

Keywords

IranOpium tinctureOpioid substitution treatmentRandomized clinical trial
Type
Abstract
Information
European Psychiatry , Volume 64 , Special Issue S1: Abstracts of the 29th European Congress of Psychiatry , April 2021 , pp. S171
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of the European Psychiatric Association
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