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IRCT138708261457N1 IRCT 2007-12-22 Mazandaran University of Medical Sciences Tramadol versus Methadone for the Management of Severe Heroin Withdrawal Tramadol versus Methadone for the Management of Severe Heroin Withdrawal 2007-12-22 anticipated 70 Complete https://irct.ir/trial/719 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Heroin Withdrawal. Intervention 1: Methadone (60 mg/day) for 3 days and then the dose was gradually lowered (tapered 20% per 48 hours from the initial dose) until the end of 2nd week when it was discontinued. Intervention 2: Tramadol (600 mg/day) for 3 days and then the dose was gradually lowered (tapered 20% per 48 hours from the initial dose) until the end of 2nd week when it was discontinued.
public Mehran Zarghami
Zare Hospital, Neka Road
Sari Iran (Islamic Republic of) 4815466848 +98 15 1226 3763 mzarghami@mazums.ac.ir & mehran.zarghami@gmail.com Mazandaran University of Medical Sciences scientific Mehran Zarghami
Zare Hospital Neka Road
Sari Iran (Islamic Republic of) 4815466848 +98 15 1226 3763 mzarghami@mazums.ac.ir & mehran.zarghami@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Male F11.3 Mental and behavioural disorders due to psychoactive substance use (withdrawal state) Treatment - Drugs Treatment - Drugs Methadone (60 mg/day) for 3 days and then the dose was gradually lowered (tapered 20% per 48 hours from the initial dose) until the end of 2nd week when it was discontinued Tramadol (600 mg/day) for 3 days and then the dose was gradually lowered (tapered 20% per 48 hours from the initial dose) until the end of 2nd week when it was discontinued Management of heroin withdrawal. Timepoint: days 4, 6, 8, 10, 14. Method of measurement: Objective Opioid Withdrawal Scale (OOWS). Risk of respiratory depression. Timepoint: days 4, 6, 8, 10, 14. Method of measurement: physical examination and checklist. Mazandaran University of Medical Sciences Approved 2007-12-11 Ethics committee, Vice Chancellor for Research Building No 2, Mazandaran University of Medical Sciences, Moallem Square, Sari, Mazandaran, IR Iran Sari Iran (Islamic Republic of)