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IRCT2016041627413N1 IRCT 2016-05-21 Vice chancellor for research,Kashan University of Medical Sciences Efficacy of automoxetine in methamphetamine dependency Efficacy of Atomoxetine for methamphetamine users who are on methadone maintenance treatment(Randomized, double-blind, placebo-controlled clinical trials) 2016-01-21 anticipated 82 Complete https://irct.ir/trial/22447 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A methamphetamine dependence. Intervention 1: The intervention group.: Automoxetine 40 mg daily for 8 weeks. Intervention 2: the control group:placebo for 8 weeks.
public Ali Rabiey
Ravandi Boulevard, Kashan University of Medical Sciences ,School of Medicine of medical sciences
kashan Iran (Islamic Republic of) +98 31 5562 1181 rabiey-a@kaums.ac.ir kashan university of Medical Sciences scientific Hamid Reza Banafshe
Ravandi Boulevard, Kashan University of Medical Sciences ,School of Medicine
Kashan Iran (Islamic Republic of) +98 31 5554 2999 Banafshe57@hotmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria:18-65 years old؛ On Methadone maintenance treatment؛ Seeking treatment for METH use؛ METH dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV؛ At least weekly self-reported METH use during a preceding three month period؛ Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing, and not be nursing؛ Men must agree to use effective means of contraception during the study. Exclusion Criteria: Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician؛ Current opioid, alcohol or sedative physical dependence or cocaine dependence؛ Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, hypertension [i.e., > 160 SBP or > 100 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician؛ Schizophrenia or bipolar disorder of any type؛ present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with atomoxetine (e.g., an monoamine oxidase inhibitor (MAOI), paroxetine, fluoxetine, quinidine, dopamine, albuterol, or other β2-agonists)؛ Medical contraindication to receiving atomoxetine (e.g., severe hepatic impairment, glaucoma, heart disease, hypertension, seizure disorders, documented hypersensitivity to atomoxetine); or other bronchospastic condition, (2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to atomoxetine)؛ Liver function tests (i.e., liver enzymes) greater than two times normal levels؛ Systolic blood pressure of < 90 or > 160 mmHg, diastolic blood pressure of < 60 or > 100 mmHg, or sitting heart rate of < 55 or > 100 beats/min or blood pressure readings > 140 systolic or > 90 diastolic on three separate, consecutive occasions؛ History of pheochromocytoma؛ Metabolic diseases such as diabetes and neurological diseases such as epilepsy؛ Pregnant or nursing female 18 years 50 years Both F15 Mental and behavioural disorders due to use of other stimulants, including caffeine Treatment - Drugs Placebo The intervention group.: Automoxetine 40 mg daily for 8 weeks. the control group:placebo for 8 weeks Negative urine test for methamphetamine. Timepoint: twice a week. Method of measurement: methamphetamine urine test. Measure of desire for methamphetamine. Timepoint: Once every ten days. Method of measurement: by desire for drug questionnaire. Evaluation of methamphetamine withdrawal symptoms. Timepoint: Once every ten days. Method of measurement: Methamphetamine Withdrawal Questionnaire. - - Vice chancellor for research,Kashan University of Medical Sciences Approved 2016-02-25 Ethics committee of Kashan University of Medical Sciences Ravandi Boulevard, Kashan University of Medical Sciences ,School of Medicine Kashan Iran (Islamic Republic of)