Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial. (7th September 2022)

• Record Type: Journal Article
• Authors: Nikoo, Mohammadali; Kianpoor, Kiana; Nikoo, Nooshin; Javidanbardan, Sanam; Kazemi, Alireza; Choi, Fiona; Vogel, Marc; Gholami, Ali; Tavakoli, Saeed; Wong, James S. H.; Moazen‐Zadeh, Ehsan; Givaki, Reza; Jazani, Majid; Mohammadian, Fatemeh; Moghaddam, Nader Markazi; Schütz, Christian; Jang, Kerry; Akhondzadeh, Shahin; Krausz, Michael
• Is Part Of: Addiction. Volume 118:Number 2(2023)
• Page Start: 284
• Page End: 294
• Publication Date: 2022-09-07
• Subjects: Clinical trial -- methadone -- opioid agonist treatment -- opioid substitution treatment -- opium -- opium tincture -- retention; Alcoholism -- Periodicals; Drug addiction -- Periodicals; 616.86
• DOI: 10.1111/add.16030
• Languages: English
• ISSNs: 0965-2140

Abstract

Abstract: 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.