Psychoactive substance use. Mental and behavioural disorders due to psychoactive substance use
Conditions
Interventions
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 a
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.
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadhadi Farahzadi
School of Advanced Technologies in Medicine, Tehran University of Medical Sciences Tehran
Outcome results
None listed