TY - JOUR
T1 - Opium tincture versus methadone for opioid agonist treatment
T2 - a randomized controlled trial
AU - Nikoo, Mohammadali
AU - Kianpoor, Kiana
AU - Nikoo, Nooshin
AU - Javidanbardan, Sanam
AU - Kazemi, Alireza
AU - Choi, Fiona
AU - Vogel, Marc
AU - Gholami, Ali
AU - Tavakoli, Saeed
AU - Wong, James S.H.
AU - Moazen-Zadeh, Ehsan
AU - Givaki, Reza
AU - Jazani, Majid
AU - Mohammadian, Fatemeh
AU - Moghaddam, Nader Markazi
AU - Schütz, Christian
AU - Jang, Kerry
AU - Akhondzadeh, Shahin
AU - Krausz, Michael
N1 - Funding Information:
Financial support for this study was received from the Iran National Science Foundation, Grant/Award Number: 93045481; Tehran University of Medical Sciences and Health Services, Grant/Award number: 28099; and AJA University of Medical Sciences, Grant/Award numbers: 2/12/95. M.N. is supported by Frederick Banting and Charles Best Canada Graduate Scholarships (Funding Reference number = 157934).
Publisher Copyright:
© 2022 Society for the Study of Addiction.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
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.
KW - Clinical trial
KW - methadone
KW - opioid agonist treatment
KW - opioid substitution treatment
KW - opium
KW - opium tincture
KW - retention
UR - http://www.scopus.com/inward/record.url?scp=85137583637&partnerID=8YFLogxK
U2 - 10.1111/add.16030
DO - 10.1111/add.16030
M3 - Article
AN - SCOPUS:85137583637
SN - 0965-2140
VL - 118
SP - 284
EP - 294
JO - Addiction
JF - Addiction
IS - 2
ER -