opioid dependence. Mental and behavioural disorders due to use of opioids
Conditions
Interventions
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
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
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention in treatment. Timepoint: 3 months. Method of measurement: number (percentage of patients in the treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMichael Krausz
University of British Columbia
Outcome results
None listed