IRCT201506261556N78
Completed
Phase 3
Comparison of Opium Tincture (OT) and Methadone for Maintenance Treatment of Opioid Dependence: A Randomized Double-blind Controlled Clinical Trial
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 240
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- no limit to no limit (—)
- Sex
- All
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
- Not provided
Investigators
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