IRCT2016012826168N1 IRCT 2016-05-01 Vice chancellor for research, Tehran University of Medical Sciences Evaluation of efficacy of Riluzole in the treatment of Methamphetamine Evaluation of efficacy of Riluzole compared with placebo in the treatment of Methamphetamine dependence: A randomized, double-blind, placebo-controlled trial 2016-02-20 anticipated 40 Complete https://irct.ir/trial/21754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Psychoactive substance use. Intervention 1: Intervention group: 20 patients are treated with Riluzole. The duration of therapy is 3 months and the dosage of Riluzole is twice per day. Intervention 2: Control group: 20 patients are treated with placebo. The duration of therapy is 3 months and the dosage of placebo is twice per day.

public Mohammadhadi Farahzadi

Addiction Treatment Center; Edalat square; Azadshahr; Yazd; Iran

Yazd Iran (Islamic Republic of) +98 35 3722 8264 Mh-farahzadi@razi.tums.ac.ir; Dr.farahzadi@yahoo.com School of Advanced Technologies in Medicine, Tehran University of Medical Sciences Tehran Iran (Islamic Republic of) Inclusion criteria: Dependence to Methamphetamine according to DSM-IV criteria, consent and commitment for treatment cooperation, age above 18 and under 65. Exclusion criteria: Past history of sensitivity to Riluzole؛ past history of structural or functional liver disease or abnormal liver function tests (Ast, Alt). 5fold increase in liver enzymes test (Ast,Alt) or jaundice؛ abnormal renal function tests at the beginning of the study؛ interstitial lung disease or hypersensitive pneumonitis؛ neutropenia؛ pregnancy or lactation؛ developing psychiatric disorders or previous neurologic disorders like psychosis؛ bipolar disorders؛ major depression, tic disorders؛ Tourette's syndrome or any psychiatric disorders that need medical therapy or makes dependency to addiction therapy complicated; developing significant clinical cardiovascular disorders؛ physical exam or electrocardiography؛ family history of disability or premature cardiovascular mortality in first degree relatives؛ past history of severe untreated physical disabilities؛ abnormal vital signs. 18 years 65 years Both F10, F11, Mental and behavioural disorders due to psychoactive substance use Treatment - Drugs Placebo Intervention group: 20 patients are treated with Riluzole. The duration of therapy is 3 months and the dosage of Riluzole is twice per day. Control group: 20 patients are treated with placebo. The duration of therapy is 3 months and the dosage of placebo is twice per day. Adherence to treatment. Timepoint: Once a week. Method of measurement: Refer the patient to receive the drug(questionnaire). The proportion of negative urine test results. Timepoint: Once a week. Method of measurement: urine test. Depression. Timepoint: Beginning and end of treatment. Method of measurement: Hamilton Depression Rating Scale. Craving for methamphetamine. Timepoint: Monthly. Method of measurement: questionnaire. Addiction Severity. Timepoint: Monthly. Method of measurement: ASI: Addiction Severity Index. Methamphetamine dependence. Timepoint: Monthly. Method of measurement: ASI: Addiction Severity Index Questionnaire. Clinical examination of the pulse, and blood pressure. Timepoint: On admission and then weekly. Method of measurement: Clinical examination. Riluzole side effects. Timepoint: Weekly. Method of measurement: questionnaire. Vice chancellor for research, Tehran University of Medical Sciences Approved 2016-01-10 Tehran University of Medical Sciences Tehran University of Medical Sciences; Tehran; Iran Tehran Iran (Islamic Republic of)