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IRCT201506261556N78 IRCT 2015-07-26 Tehran University of Medical Sciences Opium trial Comparison of Opium Tincture (OT) and Methadone for Maintenance Treatment of Opioid Dependence: A Randomized Double-blind Controlled Clinical Trial 2015-09-01 anticipated 240 Complete https://irct.ir/trial/927 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 opioid dependence. Intervention 1: Intervention group: Opium with patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population. Intervention 2: Active comparator: Methadone with patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population.
public Michael Krausz
number 430-5950, David Strangway Bldg, University Blvd
Vancouver Canada V6T 1Z3 0016048273975 michael.krausz@ubc.ca University of British Columbia scientific Shahin Akhondzadeh
Number 101, education bldg., Roozbeh Psychiatry Hospital, south Kargar street
Tehran Iran (Islamic Republic of) +98 215412222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Opioid dependence as confirmed by DSM V diagnostic criteria; Willingness and ability to adhere to study protocol and follow-up schedule as determined through the pre-randomization period; Provide written informed consent; Females of childbearing capacity must agree to use an acceptable method of birth control approved by the study investigator throughout the study. Exclusion criteria: Active participant in another treatment program for opioid dependence within 14 days before inclusion in the study; Severe hepatic impairment (decompensated liver disease): a contraindication for methadone and its potential to precipitate hepatic encephalopathy; Hypersensitivity to methadone syrup or other ingredients in the formulation; Pregnancy; Severe chronic respiratory disease; Head injury and raised intracranial pressure: Respiratory depressant effects (with CO2 retention and secondary elevation of CSF pressure) may be markedly exaggerated in the presence of head injury, or a pre-existing increase in intracranial pressure. May produce effects that obscure the clinical course in participants with head injuries; Biliary tract disease: may cause constriction of sphincter of Oddi; Monoamine oxidase inhibitors use within 14 days of the study. no limit no limit Both F11 Mental and behavioural disorders due to use of opioids Treatment - Drugs Treatment - Drugs Intervention group: Opium with patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population Active comparator: Methadone with patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population Retention in treatment. Timepoint: 3 months. Method of measurement: number (percentage of patients in the treatment). Craving. Timepoint: Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly. Method of measurement: VAS. Withdrawal symptoms. Timepoint: Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly. Method of measurement: subjective opiate withdrawal scale (SOWS). Physical health. Timepoint: Baseline, month 1, 2 and 3. Method of measurement: Opiate treatment index (OTI)-health section. Mental health. Timepoint: Baseline, month 1, 2 and 3. Method of measurement: Symptom Checklist 90 (SCL-90). Severity of substance use problem. Timepoint: Baseline, month 1, 2 and 3. Method of measurement: Addiction Severity Index. Cognitive function. Timepoint: Baseline, month 1, 2 and 3. Method of measurement: Montreal Cognitive Assessment (MOCA). Quality of life. Timepoint: Baseline, month 1, 2 and 3. Method of measurement: WHOQOL–BREF. Client Satisfaction. Timepoint: month 3. Method of measurement: Treatment Perceptions Questionnaire (TPQ). Abstinence. Timepoint: Baseline, month 1, 2 and 3. Method of measurement: self-report & urine toxicology. Safety. Timepoint: Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly. Method of measurement: Adverse Events Report Form. Cost- effectiveness. Timepoint: month 3. Method of measurement: QALY. Tehran University of Medical Sciences Approved 2015-05-11 Clinical Research Ethics Board (CREB) of University of British Columbia (UBC) Room 210, 828 West, 10th Avenue Vancouver BC Canada