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IRCT20160813029315N2 IRCT 2019-06-27 Mental Health Research Center The efficacy of desipramine in reducing methamphetamine craving Placebo-controlled randomized clinical trial testing the efficacy of desipramine in reducing craving in patients with methamphetamine use disorder 2016-06-03 anticipated 40 Complete https://irct.ir/trial/23598 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: An independent researcher will randomly allocate eligible participants to treatment vs. placebo group by block randomization method with random block size using Random Allocation Software version 1.0.0. Generated codes with the associated pills (desipramine or placebo) will be inserted into opaque sealed envelopes, Blinding description: All patients, the corresponding researcher, physicians, nurses, people responsible to gather data, and individuals who evaluate outcomes will be blinded to the allocations. 2-3 Metamphetamine use disorder. Intervention 1: Intervention group: Half of participants will be treated by desipramine (Exir pharmaceutical company) at the dose of 50 mg once per day orally and gradually increasing to 100 mg once per day and continued for 12 weeks. Intervention 2: Control group: Half of participants will receive placebo. Placebo will be started identically as the shape of desipramine with the dose of 50 mg once per day orally and gradually increased to 100 mg once per day and continued for 12 weeks. Placebo and desipramine will be of the same shape, appearance, size, texture, color, and odor. Yes - There is a plan to make this available What will be shared: The SPSS file containing data of participants is sharable. When: Data will be shared 6 months after publishing the results. To whom: Researchers could request to receive the data. Conditions: Various analysis based of sample size is performable. Where to obtain: To receive data one should email the corresponding researcher. How to obtain: Two weeks after an inquiry email one would receive the data. Comments:
public Dr. Hamidreza Ahmadkhaniha
7th km Karaj Special Road, Iran Psychiatric Hospital
Tehran Iran (Islamic Republic of) 1398913151 +98 21 4452 5615 dr_ahmadkhaniha@yahoo.com Iran University of Medical Sciences scientific Ila Daryoushfar
7th km Karaj Special Road, Iran Psychiatric Hospital
Tehran Iran (Islamic Republic of) 1398913151 +98 21 6655 1515 ila_darioushfar@yahoo.com Psychiatry department, Iran University of Mrdical Science Iran (Islamic Republic of) Age between 18 to 50 Current diagnosis of methamphetamine use disorder based on DSM IV-TR criteria Positive urine test for methamphetamine prior to study entry Male gender 18 years 50 years Male Having conditions known to be deteriorated following desipramine use such as obesity, liver diseases, and cardiovascular diseases Taking antidepressants of any class in during the two weeks prior to entering the study Taking medications with potential effect on methamphetamine craving (i.e. modafinil, bupropion, naltrexone, N-acetylcysteine) Taking medications known to adversely interact with desipramine Serious mood disorders, suicidal ideation, and psychotic disorders requiring hospitalization Comorbid medical conditions, as revealed by history review, physical exam, or laboratory results of blood chemistry test and liver profile Incidence of a life-threatening side effect following medication use (i.e. liver failure, pancreatitis, hepatic encephalopathy, thrombocytopenia, leucopenia) Medication intolerance Use of other substances (except methadone maintenance therapy, nicotine, cannabis, and morphine) confirmed by a toxicology screen Currently (during a month prior to study) in treatment for methamphetamine use Having DSM IV-TR diagnosis of other substance use disorders in the past year No longer willing to participate in the study F15.20 Other stimulant dependence, uncomplicated Treatment - Drugs Treatment - Drugs Intervention group: Half of participants will be treated by desipramine (Exir pharmaceutical company) at the dose of 50 mg once per day orally and gradually increasing to 100 mg once per day and continued for 12 weeks. Control group: Half of participants will receive placebo. Placebo will be started identically as the shape of desipramine with the dose of 50 mg once per day orally and gradually increased to 100 mg once per day and continued for 12 weeks. Placebo and desipramine will be of the same shape, appearance, size, texture, color, and odor. Metamphemine craving. Timepoint: before intervention, at the end of each month after intervention until 4 months (0-1-2-3-4). Method of measurement: Cocaine Craving Questionnaire-Brief. Positive urine toxicology test for methamphetamine. Timepoint: Before intervention, at the end of each month after intervention until 4 months (0-1-2-3-4). Method of measurement: Urine toxicology test. Drug Side Effects. Timepoint: Before intervention and at the end of each month after intervention until 4 months (0-1-2-3-4). Method of measurement: Side effects questionnaire. Mental Health Research Center Approved 2015-06-25 Ethics Committee of Iran University of Medical Sciences 5th floor, central head quarter, Iran University of Medical Sciences, Hemmat highway Tehran Tehran Iran (Islamic Republic of)