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Participants were provided treatment and followed for a period of 85\u2009days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Four OAT clinics in Iran.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>Two hundred and four participants with opioid use disorder [mean age (standard deviation)\u2009=\u200937.4 (9.3); female 11.3%] recruited between July 2017 and January 2018.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Participants were assigned to either OT (102) or methadone (102) using a patient\u2010centred flexible dosing strategy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Measurements<\/jats:title><jats:p>Treatment retention over 85\u2009days was the primary outcome. Self\u2010reported opioid use outside treatment and occurrence of adverse events (AEs) were the secondary outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Remaining in treatment at the end of the follow\u2010up 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\u2010to\u2010treat and per\u2010protocol analyses; non\u2010inferiority was not supported statistically, as the upper bound of the confidence interval exceeded our pre\u2010specified non\u2010inferiority margin (1.25). Opioid use outside treatment was reported by 30.3% of OT (<jats:italic>n<\/jats:italic>\u2009=\u2009152) and 49.4% of methadone (<jats:italic>n<\/jats:italic>\u2009=\u2009168) patients, a difference in proportions of \u221219%: 90% confidence interval (\u221228%, \u221210%). The total count of AEs in the OT arm (22 among nine individuals) was significantly higher (<jats:italic>P<\/jats:italic>\u2009=\u20090.04) than that in the methadone arm (three among two individuals). Nausea was the most common side effect.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>While this study could not conclude the non\u2010inferiority of opium tincture (OT) to methadone for retaining patients in opioid agonist treatment, OT retained 60% of participants to end of follow\u2010up (85\u2009days) and was superior to methadone in reducing self\u2010reported opioid use outside treatment.<\/jats:p><\/jats:sec>","DOI":"10.1111\/add.16030","type":"journal-article","created":{"date-parts":[[2022,8,16]],"date-time":"2022-08-16T05:07:58Z","timestamp":1660626478000},"page":"284-294","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial"],"prefix":"10.1111","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7692-3923","authenticated-orcid":false,"given":"Mohammadali","family":"Nikoo","sequence":"first","affiliation":[{"name":"Institute of Mental Health, Department of Psychiatry, Faculty of Medicine University of British Columbia  Vancouver BC Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiana","family":"Kianpoor","sequence":"additional","affiliation":[{"name":"Institute of Mental Health, Department of Psychiatry, Faculty of Medicine University of British Columbia  Vancouver BC Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nooshin","family":"Nikoo","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of British Columbia  Vancouver BC Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanam","family":"Javidanbardan","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of British Columbia  Vancouver BC Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alireza","family":"Kazemi","sequence":"additional","affiliation":[{"name":"Institute of Mental Health, Department of Psychiatry, Faculty of Medicine University of British Columbia  Vancouver BC Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fiona","family":"Choi","sequence":"additional","affiliation":[{"name":"Institute of Mental Health, Department of Psychiatry, Faculty of Medicine University of British Columbia  Vancouver BC Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3088-0331","authenticated-orcid":false,"given":"Marc","family":"Vogel","sequence":"additional","affiliation":[{"name":"Division of Substance Use Disorders, Psychiatric Services of Thurgovia  M\u00fcnsterlingen Switzerland"},{"name":"Division of Substance Use Disorders University of Basel Psychiatric Clinics  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ali","family":"Gholami","sequence":"additional","affiliation":[{"name":"Kian Methadone Maintenance Treatment Clinic, Private Practice  Sari Mazandaran Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saeed","family":"Tavakoli","sequence":"additional","affiliation":[{"name":"Rooz\u2010e\u2010No, Methadone Maintenance Treatment Clinic (Private Practice)  Shiraz Fars Iran"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3030-311X","authenticated-orcid":false,"given":"James S. 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