PMID- 35971297
OWN - NLM
STAT- MEDLINE
DCOM- 20230104
LR  - 20230225
IS  - 1360-0443 (Electronic)
IS  - 0965-2140 (Linking)
VI  - 118
IP  - 2
DP  - 2023 Feb
TI  - Opium tincture versus methadone for opioid agonist treatment: a randomized 
      controlled trial.
PG  - 284-294
LID - 10.1111/add.16030 [doi]
AB  - AIM: To test if opium tincture (OT) was non-inferior to methadone in retaining 
      participants in opioid agonist treatment (OAT). DESIGN: A Phase III, 
      multi-centre, parallel-group, non-inferiority, double-blind randomized controlled 
      trial with an allocation ratio of 1:1. Participants were provided treatment and 
      followed for a period of 85 days. SETTING: Four OAT clinics in Iran. 
      PARTICIPANTS: Two hundred and four participants with opioid use disorder [mean 
      age (standard deviation) = 37.4 (9.3); female 11.3%] recruited between July 2017 
      and January 2018. INTERVENTIONS: Participants were assigned to either OT (102) or 
      methadone (102) using a patient-centred flexible dosing strategy. MEASUREMENTS: 
      Treatment retention over 85 days was the primary outcome. Self-reported opioid 
      use outside treatment and occurrence of adverse events (AEs) were the secondary 
      outcomes. FINDINGS: Remaining in treatment at the end of the follow-up were 68.6% 
      in the methadone arm and 59.8% in the OT arm. The relative retention rate of 
      methadone to OT was 1.15 (0.97, 1.36) in both intent-to-treat and per-protocol 
      analyses; non-inferiority was not supported statistically, as the upper bound of 
      the confidence interval exceeded our pre-specified non-inferiority margin (1.25). 
      Opioid use outside treatment was reported by 30.3% of OT (n = 152) and 49.4% of 
      methadone (n = 168) patients, a difference in proportions of -19%: 90% confidence 
      interval (-28%, -10%). The total count of AEs in the OT arm (22 among nine 
      individuals) was significantly higher (P = 0.04) than that in the methadone arm 
      (three among two individuals). Nausea was the most common side effect. 
      CONCLUSION: While this study could not conclude the non-inferiority of opium 
      tincture (OT) to methadone for retaining patients in opioid agonist treatment, OT 
      retained 60% of participants to end of follow-up (85 days) and was superior to 
      methadone in reducing self-reported opioid use outside treatment.
CI  - (c) 2022 Society for the Study of Addiction.
FAU - Nikoo, Mohammadali
AU  - Nikoo M
AUID- ORCID: 0000-0002-7692-3923
AD  - Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, 
      University of British Columbia, Vancouver, BC, Canada.
FAU - Kianpoor, Kiana
AU  - Kianpoor K
AD  - Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, 
      University of British Columbia, Vancouver, BC, Canada.
FAU - Nikoo, Nooshin
AU  - Nikoo N
AD  - Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
FAU - Javidanbardan, Sanam
AU  - Javidanbardan S
AD  - Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
FAU - Kazemi, Alireza
AU  - Kazemi A
AD  - Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, 
      University of British Columbia, Vancouver, BC, Canada.
FAU - Choi, Fiona
AU  - Choi F
AD  - Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, 
      University of British Columbia, Vancouver, BC, Canada.
FAU - Vogel, Marc
AU  - Vogel M
AUID- ORCID: 0000-0002-3088-0331
AD  - Division of Substance Use Disorders, Psychiatric Services of Thurgovia, 
      Munsterlingen, Switzerland.
AD  - Division of Substance Use Disorders, University of Basel Psychiatric Clinics, 
      Basel, Switzerland.
FAU - Gholami, Ali
AU  - Gholami A
AD  - Kian Methadone Maintenance Treatment Clinic, Private Practice, Sari, Mazandaran, 
      Iran.
FAU - Tavakoli, Saeed
AU  - Tavakoli S
AD  - Rooz-e-No, Methadone Maintenance Treatment Clinic (Private Practice), Shiraz, 
      Fars, Iran.
FAU - Wong, James S H
AU  - Wong JSH
AUID- ORCID: 0000-0003-3030-311X
AD  - Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, 
      University of British Columbia, Vancouver, BC, Canada.
AD  - Complex Pain and Addiction Consult Service, Vancouver General Hospital, 
      Vancouver, BC, Canada.
FAU - Moazen-Zadeh, Ehsan
AU  - Moazen-Zadeh E
AUID- ORCID: 0000-0003-0846-1402
AD  - Addiction Institute of Mount Sinai, Department of Psychiatry, Icahn School of 
      Medicine at Mount Sinai, NY, USA.
FAU - Givaki, Reza
AU  - Givaki R
AD  - Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, 
      Iran.
FAU - Jazani, Majid
AU  - Jazani M
AD  - Sales, Marketing, Export and Medical Department, Darou Pakhsh Pharmaceutical 
      Manufacturing Company, Tehran, Iran.
FAU - Mohammadian, Fatemeh
AU  - Mohammadian F
AD  - Sales, Marketing, Export and Medical Department, Darou Pakhsh Pharmaceutical 
      Manufacturing Company, Tehran, Iran.
FAU - Moghaddam, Nader Markazi
AU  - Moghaddam NM
AD  - Department of Health Management and Economics, School of Medicine, AJA University 
      of Medical Sciences, Tehran, Iran.
FAU - Schutz, Christian
AU  - Schutz C
AD  - Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, 
      University of British Columbia, Vancouver, BC, Canada.
FAU - Jang, Kerry
AU  - Jang K
AD  - Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, 
      University of British Columbia, Vancouver, BC, Canada.
FAU - Akhondzadeh, Shahin
AU  - Akhondzadeh S
AD  - Psychiatric Research Center, Roozbeh Hospital, Department of Psychiatry, Faculty 
      of Medicine, Tehran University of Medical Sciences, Iran.
FAU - Krausz, Michael
AU  - Krausz M
AD  - Institute of Mental Health, Centre for Health Evaluation and Outcome Sciences, 
      Department of Psychiatry, Faculty of Medicine, University of British Columbia, 
      Vancouver, BC, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT02502175
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220907
PL  - England
TA  - Addiction
JT  - Addiction (Abingdon, England)
JID - 9304118
RN  - UC6VBE7V1Z (Methadone)
RN  - 8008-60-4 (Opium)
RN  - 0 (Analgesics, Opioid)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Methadone/therapeutic use
MH  - Opium/therapeutic use
MH  - Analgesics, Opioid/therapeutic use
MH  - *Opioid-Related Disorders/drug therapy/rehabilitation
MH  - Double-Blind Method
MH  - Opiate Substitution Treatment/methods
OTO - NOTNLM
OT  - Clinical trial
OT  - methadone
OT  - opioid agonist treatment
OT  - opioid substitution treatment
OT  - opium
OT  - opium tincture
OT  - retention
EDAT- 2022/08/17 06:00
MHDA- 2023/01/05 06:00
CRDT- 2022/08/16 01:13
PHST- 2021/08/02 00:00 [received]
PHST- 2022/08/03 00:00 [accepted]
PHST- 2022/08/17 06:00 [pubmed]
PHST- 2023/01/05 06:00 [medline]
PHST- 2022/08/16 01:13 [entrez]
AID - 10.1111/add.16030 [doi]
PST - ppublish
SO  - Addiction. 2023 Feb;118(2):284-294. doi: 10.1111/add.16030. Epub 2022 Sep 7.