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Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial.
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.
Afiliación
  • Nikoo M; Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Kianpoor K; Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Nikoo N; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Javidanbardan S; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Kazemi A; Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Choi F; Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Vogel M; Division of Substance Use Disorders, Psychiatric Services of Thurgovia, Münsterlingen, Switzerland.
  • Gholami A; Division of Substance Use Disorders, University of Basel Psychiatric Clinics, Basel, Switzerland.
  • Tavakoli S; Kian Methadone Maintenance Treatment Clinic, Private Practice, Sari, Mazandaran, Iran.
  • Wong JSH; Rooz-e-No, Methadone Maintenance Treatment Clinic (Private Practice), Shiraz, Fars, Iran.
  • Moazen-Zadeh E; Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Givaki R; Complex Pain and Addiction Consult Service, Vancouver General Hospital, Vancouver, BC, Canada.
  • Jazani M; Addiction Institute of Mount Sinai, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, NY, USA.
  • Mohammadian F; Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
  • Moghaddam NM; Sales, Marketing, Export and Medical Department, Darou Pakhsh Pharmaceutical Manufacturing Company, Tehran, Iran.
  • Schütz C; Sales, Marketing, Export and Medical Department, Darou Pakhsh Pharmaceutical Manufacturing Company, Tehran, Iran.
  • Jang K; Department of Health Management and Economics, School of Medicine, AJA University of Medical Sciences, Tehran, Iran.
  • Akhondzadeh S; Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
  • Krausz M; Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Addiction ; 118(2): 284-294, 2023 02.
Article en En | MEDLINE | ID: mdl-35971297
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Metadona / Trastornos Relacionados con Opioides Tipo de estudio: Clinical_trials / Guideline Límite: Female / Humans Idioma: En Revista: Addiction Asunto de la revista: TRANSTORNOS RELACIONADOS COM SUBSTANCIAS Año: 2023 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Metadona / Trastornos Relacionados con Opioides Tipo de estudio: Clinical_trials / Guideline Límite: Female / Humans Idioma: En Revista: Addiction Asunto de la revista: TRANSTORNOS RELACIONADOS COM SUBSTANCIAS Año: 2023 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido