Tramadol versus Methadone for the Management of Severe Heroin Withdrawal
Phase 2
- Conditions
- Heroin Withdrawal.Mental and behavioural disorders due to psychoactive substance use (withdrawal state)
- Registration Number
- IRCT138708261457N1
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 70
Inclusion Criteria
DSM-IV-TR criteria for opioids dependence, current heroin dependence (i.e. withdrawal symptoms), age more than 18 years old
Exclusion criteria: physical illness that needed tramadol and/or methadone consumption, using other substances except nicotine (other opioids, cannabinoids, alcohol and benzodiazepines etc.), major psychiatry disorders such as mood disorders (unipolar and bipolar), anxiety and psychotic disorders, major physical diseases such as hepatitis, tuberculosis, AIDS and so on, history of seizures
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Management of heroin withdrawal. Timepoint: days 4, 6, 8, 10, 14. Method of measurement: Objective Opioid Withdrawal Scale (OOWS).
- Secondary Outcome Measures
Name Time Method Risk of respiratory depression. Timepoint: days 4, 6, 8, 10, 14. Method of measurement: physical examination and checklist.