Mohammadali Nikoo1, Ehsan Moazen-Zadeh1,2, Nooshin Nikoo3, Sanam Javidanbardan3, Alireza Kazemi3,4, Fiona Choi1, Marc Vogel5, Ali Gholami6, Saeed Tavakoli7, Reza Givaki8, Majid Jazani9, Fatemeh Mohammadian10, Nader Markazi Moghaddam11, Nasser Goudarzi12, Christian Schutz13, Kerry Jang13, Shahin Akhondzadeh2, Michael Krausz1. 1. Addiction and Concurrent Disorders Group, Institute of Mental Health, Centre for Health Evaluation and Outcome Sciences, Department of Psychiatry, University of British Columbia, Vancouver, Canada. 2. Psychiatric Research Center, Roozbeh Hospital, Department of Psychiatry, Tehran University of Medical Sciences, Tehran, Iran. 3. Addiction and Concurrent Disorders Group, Institute of Mental Health, Department of Psychiatry, University of British Columbia, Vancouver, Canada. 4. Health Information Management and Technology Group, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 5. Department of Psychiatry (UPK), Division of Addictive Disorders, University of Basel, Basel, Switzerland. 6. Kian Methadone Maintenance Treatment Clinic, Private Practice and Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran. 7. Rooz-e-No Methadone Maintenance Treatment Clinic, Private Practice and Shiraz University of Medical Sciences, Shiraz, Fars, Iran. 8. Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. 9. Sales, Marketing, Export, and Medical Department, Darou Pakhsh Pharmaceutical Mfg.Co., Tehran, Iran. 10. Pharmacovigilance & Clinical Trial Manager, Darou Pakhsh Pharmaceutical Mfg Co., Tehran, Iran. 11. Department of Health Management and Economics, School of Medicine, AJA University of Medical Sciences, Tehran, Iran. 12. Department of Psychology, AJA University of Medical Sciences, Tehran, Iran. 13. Institute of Mental Health, Department of Psychiatry, Faculty of Medicine, University of British Columbia, Vancouver, Canada.
Abstract
OBJECTIVES: This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder. METHODS: In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175). RESULTS: To be reported after final analysis. CONCLUSIONS: If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.
RCT Entities:
OBJECTIVES: This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder. METHODS: In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175). RESULTS: To be reported after final analysis. CONCLUSIONS: If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.