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Opium Tincture Versus Methadone for Opioid Agonist Treatment: A Randomized Controlled Trial Publisher Pubmed



Nikoo M1 ; Kianpoor K1 ; Nikoo N2 ; Javidanbardan S2 ; Kazemi A1 ; Choi F1 ; Vogel M3, 4 ; Gholami A5 ; Tavakoli S6 ; Wong JSH1, 7 ; Moazenzadeh E8 ; Givaki R9 ; Jazani M10 ; Mohammadian F10 Show All Authors
Authors
  1. Nikoo M1
  2. Kianpoor K1
  3. Nikoo N2
  4. Javidanbardan S2
  5. Kazemi A1
  6. Choi F1
  7. Vogel M3, 4
  8. Gholami A5
  9. Tavakoli S6
  10. Wong JSH1, 7
  11. Moazenzadeh E8
  12. Givaki R9
  13. Jazani M10
  14. Mohammadian F10
  15. Moghaddam NM11
  16. Schutz C1
  17. Jang K1
  18. Akhondzadeh S12
  19. Krausz M13
Show Affiliations
Authors Affiliations
  1. 1. Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
  2. 2. Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
  3. 3. Division of Substance Use Disorders, Psychiatric Services of Thurgovia, Munsterlingen, Switzerland
  4. 4. Division of Substance Use Disorders, University of Basel Psychiatric Clinics, Basel, Switzerland
  5. 5. Kian Methadone Maintenance Treatment Clinic, Private Practice, Mazandaran, Sari, Iran
  6. 6. Rooz-e-No, Methadone Maintenance Treatment Clinic (Private Practice), Fars, Shiraz, Iran
  7. 7. Complex Pain and Addiction Consult Service, Vancouver General Hospital, Vancouver, BC, Canada
  8. 8. Addiction Institute of Mount Sinai, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, NY, United States
  9. 9. Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
  10. 10. Sales, Marketing, Export and Medical Department, Darou Pakhsh Pharmaceutical Manufacturing Company, Tehran, Iran
  11. 11. Department of Health Management and Economics, School of Medicine, AJA University of Medical Sciences, Tehran, Iran
  12. 12. Psychiatric Research Center, Roozbeh Hospital, Department of Psychiatry, Faculty of Medicine, Tehran University of Medical Sciences, Iran
  13. 13. Institute of Mental Health, Centre for Health Evaluation and Outcome Sciences, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada

Source: Addiction Published:2023


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. © 2022 Society for the Study of Addiction.
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