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IRCT20180929041167N1 IRCT 2022-09-19 Iran University of Medical Sciences The effectiveness of topiramate in reducing methamphetamine craving Randomized clinical trial of the comparison of the effectiveness of topiramate in reducing craving in patients with methamphetamine use disorder 2019-07-22 anticipated 56 Complete https://irct.ir/trial/34170 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 (2, 4,8) using Random Allocation Software version 1.0.0. Generated codes with the associated pills (topiramate or placebo) will be inserted into opaque sealed envelopes, Blinding description: In this study placebo would be used. All patients, the corresponding researcher, physicians, nurses, people responsible to gather data, individuals who perform the statistical analysis, and individuals who evaluate outcomes will be blinded to the allocations. All patients will be identified by the code that has been assigned to them in the beginning of the study. The group that individuals are allocated to will be hidden from everyone except for the independent researcher (person responsible for randomization) until the study ends. At the end of the study the independent researcher who has the codes and the treatment teams assigned to them would reveal the groups to which the patients were assigned. Placebo produced by Arya pharmaceutical company is in an identical shape as of Topiramate. Placebo and topiramate will be of the same shape, appearance, size, texture, color, and odor. 2-3 Metamphetamine use disorder. Intervention 1: Intervention group: Half of the participants will be treated by topiramate (Aryia pharmaceutical company). The medication will start at the dose of 25 mg once per day orally and gradually increasing to 300 mg once per day over 45 days and will be continued for 24 weeks. Intervention 2: Control group: Half of participants will receive placebo. Placebo produced by Arya pharmaceutical company in an identicall shape as of Topiramate will be started at the dose of 25 mg once per day orally and gradually increased to 300 mg once per day over 45 days and continued for 24 weeks. Placebo and topiramate 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: Several methods of analysis can be done on the data based on the final number of sample size. 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
Iran Psychiatric Hospital, 7th km Karaj Special Road
Tehran Iran (Islamic Republic of) 1398913151 +98 21 4452 5615 dr_ahmadkhaniha@yahoo.com Iran University of Medical Sciences scientific Hasti Hadizadeh
1st floor, Tehran Psychiatric Institute, Mansouri street, Niyayesh street, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6650 6862 hasti.hadizadeh.d@gmail.com Research center for addicition and risky behaviors Iran (Islamic Republic of) Age between 18 to 65 years Current diagnosis of methamphetamine use disorder based on DSM-V criteria Positive urine test for methamphetamine prior to study entry or self report of methamphetamine use for at least 5 days during the previous month Body mass index equal or greater than 18 18 years 65 years Both Comorbid medical conditions based on medical history, physical examination, and laboratory test results Use of other substances (except for methadone as a maintenance therapy, nicotine, and cannabis) confirmed by toxicology screening Use of medications known to interact with topiramate such as acetazolamide, ergotamines, simvastatin, lovastatin, and antiepileptics History of hypersensetivity to topiramate Impaired renal function History of kidney stone Serious mood disorders (i.e. major depressive disorder, bipolar disorder), suicidal ideation, schizophrenia, psychosis (exept for transient psychosis due to substance use), dementia, psychiatric disorders requiring psychotropic medications (exept for medication for insomnia) Use of medications with potential effect on methamphetamine craving (i.e. modafinil, bupropion, naltrexone, N-acetylcycteine) Pregnancy and or lactation Currently (during a month prior to the study) in treatment for methamphetamine use Having DSM-V diagnosis of any other substance use disorders in the previous year Coronary vascular disease confirmed by physical examination and electrocardiography History of seizure History of glucoma Having DSM-V axis I psychiatric disorders that will probabely need treatment during the study duration or that are unstable Patients referred by court seeking treatment for penatly rebate F15.20 Other stimulant dependence, uncomplicated Treatment - Drugs Placebo Intervention group: Half of the participants will be treated by topiramate (Aryia pharmaceutical company). The medication will start at the dose of 25 mg once per day orally and gradually increasing to 300 mg once per day over 45 days and will be continued for 24 weeks. Control group: Half of participants will receive placebo. Placebo produced by Arya pharmaceutical company in an identicall shape as of Topiramate will be started at the dose of 25 mg once per day orally and gradually increased to 300 mg once per day over 45 days and continued for 24 weeks. Placebo and topiramate 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 6 months (0-1-2-3-4-5-6). Method of measurement: Stimulant craving questionnaire. Positive urine toxicology test for methamphetamine. Timepoint: Before intervention, at the end of each month after intervention until 6 months (0-1-2-3-4-5-6). Method of measurement: Urine toxicology test. Addiction severity index composite score. Timepoint: Before intervention, at the end of each 3 months after intervention until 6 months (0-3-6). Method of measurement: Addiction severity index-composite. Drug Side Effects. Timepoint: Before intervention and at the end of each month after intervention until 6 months (0-1-2-3-4-5-6). Method of measurement: Drug side effects questionnaire. Iran University of Medical Sciences Approved 2020-01-13 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)