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IRCT20090801002266N11 IRCT 2020-03-14 Esfahan University of Medical Sciences efficacy of memantine on opioid substances withdrawal symptoms Efficacy of Add-on Memantine to clonidine on severity of opioid substances (heroin and opium) withdrawal symptoms among opium users 2019-11-30 anticipated 60 Complete https://irct.ir/trial/43235 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the sample size of 60 people, the samples will be selected in ten blocks of six. Three person in each block will be randomly assigned to the first intervention group and three to the second intervention group, so that all six states of a six-block can be selected ten times randomly from the six blocks. By the end, thirty people will be randomly assigned to each group, Blinding description: Study participants receive medication in unnamed drug packages and do not know if the drug is placebo or memantine. The prescribing physician also does not know which patients receive placebo or memantine, and according to the list of random names of patients, the packages named A and B belong to the patients whose names are A and B, and to patients who receive Their names are given in the drug package. Outcome assessor Unaware of the Patient's Drug, assess the severity of withdrawal symptoms using a questionnaire. 3 Opioid use disorder. Intervention 1: intervention group:patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. Its daily dose is gradually reduced by ten percent per day until discontinued.Memantine is manufactured by Tesminim Company of Iran and started at a dose of 10 mg daily (5 mg twice daily) as the dose of buprenorphine began to decrease and increased to 20 mg daily (twice daily at 10 mg). And lasts up to three weeks. Intervention 2: Control group: After discontinuation of the drug, buprenorphine is started in the first dose of 2-4 mg and gradually increased until complete control of withdrawal symptoms, after complete control of withdrawal symptoms with the last dose continued for 3-5 days and then daily dose. Gradually decrease by 10 percent per day until discontinued. Placebo is given to patients in equal numbers in appearance and taste similar to memantine (in collaboration with Isfahan Pharmacy School). No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality
public Dr Gholam Reza Kheirabadi
Department of psychiatry of Isfahan University of Medical Sciences , Ostandari Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences scientific Dr Gholam Reza Kheirabadi
Department of psychiatry of Isfahan University of Medical Sciences , Ostandari Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study DSM-IV criteria for drug dependence Regular and daily use of opium orally, injectable or smoke no limit no limit Both Non-use of psychiatric drugs and other substances other than cigarettes Taking pain medications Comorbid of major psychiatric disorders Physical illness that is a prohibition on quitting drugs. F11 Opioid related disorders Treatment - Drugs Treatment - Drugs intervention group:patients in this groups will be receive Bupronorphine. Bupronorphine dose will be adjusted based on patients need and all of them will be stabilized on Bupronorphine during 3-5 days. Its daily dose is gradually reduced by ten percent per day until discontinued.Memantine is manufactured by Tesminim Company of Iran and started at a dose of 10 mg daily (5 mg twice daily) as the dose of buprenorphine began to decrease and increased to 20 mg daily (twice daily at 10 mg). And lasts up to three weeks. Control group: After discontinuation of the drug, buprenorphine is started in the first dose of 2-4 mg and gradually increased until complete control of withdrawal symptoms, after complete control of withdrawal symptoms with the last dose continued for 3-5 days and then daily dose. Gradually decrease by 10 percent per day until discontinued. Placebo is given to patients in equal numbers in appearance and taste similar to memantine (in collaboration with Isfahan Pharmacy School). Severity of opium withdrawal. Timepoint: first, third, 7th, 10th and 21th days. Method of measurement: Short Opioid Withdrawal Scale(SOWS). Esfahan University of Medical Sciences Approved 2019-11-30 Ethics committee of Isfahan University of Medical Sciences Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)