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IRCT20230606058397N1 IRCT 2023-09-18 Ahvaz University of Medical Sciences The effectiveness of mirtazapine in reducing dependence and the temptation to consume amphetamine and methamphetamine in patients ندارد Investigating the effectiveness of mirtazapine in reducing dependence and the temptation to consume amphetamine and methamphetamine patients referred to addiction treatment clinics 2023-09-23 anticipated 84 Complete https://irct.ir/trial/71749 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: First, by using the Random number generation plugin in Excel software, a table of random numbers from 1 to 84 is prepared in a non-sequential and scattered manner, and intervention and control is done by assigning numbers to two groups of 42 people. The randomization process is done by the study methodology consultant, and the clinical researchers do not know about the randomization process, and only randomized codes from 1 to 84 will be provided to them, Blinding description: This study is a double-blind, placebo-controlled trial to evaluate the effect of mirtazapine compared to placebo in reducing the use of amphetamine and methamphetamine. The intervention group will be treated with mirtazapine tablets at a dose of 15 mg per day. The control group will be treated with a placebo with the same shape, smell, taste and usage as mirtazapine. After one week, the drug consumption in both groups was doubled, so that patients in the mirtazapine group took two 15 mg tablets (30 mg in total) and patients in the placebo group took two placebo tablets. The medicine is taken at night and will last for twelve weeks. In this study, both the participants and the evaluator are unaware of the nature of both groups, on this basis, this study will be conducted in a double-blind manner. 1-2 Methamphetamine. Intervention group: 84 patients referred to Golestan hospital clinic, who were diagnosed by a psychiatric specialist based on DSM V diagnosis criteria, entered the study and were randomly assigned to one of two intervention or placebo groups. After explaining the plan to the patients, if they give their consent and complete the informed consent form, taking into account the entry and exit criteria, based on the random list prepared by the statistical consultant, they will be divided into two groups of 42 people, control and intervention. The intervention group will be treated with mirtazapine tablets at a dose of 15 mg per day. The control group will be treated with a placebo with the same shape, smell, taste and usage as mirtazapine. After one week, the drug consumption in both groups was doubled, so that patients in the mirtazapine group took two 15 mg tablets (30 mg in total) and patients in the placebo group took two placebo tablets. The medicine is taken at night and will last for twelve weeks.. Yes - There is a plan to make this available What will be shared: There is no problem with publishing When: 1403 To whom: Group of psychiatrists Conditions: The documents and data of this study can be analyzed if it is limited to the population inside Khuzestan province and this research cannot be generalized for other regions. It can be used if you only have documents and references. Where to obtain: Research Vice-Chancellor of Jundishapur University of Medical Sciences, Ahvaz medical School Psychiatry department located in Golestan Blvd, Golestan Hospital, Ahvaz. Postal code 61357-15794 Internet address journal_ajums@yahoo.com 06133113828 How to obtain: He should write a letter to the university security through the vice president of research and finally receive the documents through the vice president himself. This process takes about a week. Comments: ...
public Mohammad Hossein Salehi Kasai
Golestan Hospital, Golestan Boulevard, Ahvaz
Ahvaz Iran (Islamic Republic of) 6167642342 +98 61 3356 6523 ehsanmoradijoo@yahoo.com Ahvaz University of Medical Sciences scientific Ahmed Fakhri
Ahvaz University of Medical Sciences, Golestan Boulevard, Ahvaz
Ahvaz Iran (Islamic Republic of) 6167642342 +98 61 3356 4243 fakhri_a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) At least one positive urine test for methamphetamine during the hospitalization period Absence of current acute illness Absence of serious chronic diseases Able and willing to provide informed consent and adhere to the visit schedule 18 years 60 years Both Placebo Intervention group: 84 patients referred to Golestan hospital clinic, who were diagnosed by a psychiatric specialist based on DSM V diagnosis criteria, entered the study and were randomly assigned to one of two intervention or placebo groups. After explaining the plan to the patients, if they give their consent and complete the informed consent form, taking into account the entry and exit criteria, based on the random list prepared by the statistical consultant, they will be divided into two groups of 42 people, control and intervention. The intervention group will be treated with mirtazapine tablets at a dose of 15 mg per day. The control group will be treated with a placebo with the same shape, smell, taste and usage as mirtazapine. After one week, the drug consumption in both groups was doubled, so that patients in the mirtazapine group took two 15 mg tablets (30 mg in total) and patients in the placebo group took two placebo tablets. The medicine is taken at night and will last for twelve weeks. Decreasing addiction in patients using amphetamine and methamphetamine. Timepoint: Before starting the treatment, at the beginning of the treatment and once every two weeks (the length of the treatment is 12 weeks), the results will be measured. Method of measurement: With physical examinations and measurement of vital signs, evaluation with the dependency index questionnaire. Reducing depression in patients using amphetamine and methamphetamine. Timepoint: Before starting the treatment, at the beginning of the treatment and once every two weeks (the length of the treatment is 12 weeks), the results will be measured. Method of measurement: with Beck depression questionnaire, physical examinations and measuring vital signs. Ahvaz University of Medical Sciences Approved 2022-11-15 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Ahvaz University of Medical Sciences, Golestan Boulevard, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)