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IRCT20090801002266N15 IRCT 2021-05-06 Esfahan University of Medical Sciences Efficacy of Add-on Amantadine to clonidine on severity of opioid withdrawal symptoms. Evaluation the efficacy of Add-on Amantadine to clonidine on severity of opioid withdrawal symptoms. 2021-05-22 anticipated 86 Complete https://irct.ir/trial/55741 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Selected patients are randomly assigned to clonidine + placebo and clonidine + amantadine treatment groups.The process is such that both consecutive eligible entrants are considered as a block.The random method is such that if the random number is 4-0, it is assigned to group A and if it is 5-9, it is assigned to group B and then decodes A and B based on the type of treatment (in which drug group each patient was), Blinding description: The intervention and control groups will receive amantadine and clonidine or placebo and clonidine, respectively. The drug is administered in a double-blind manner and the investigator and the patient will not know the type of drug. 3 Severity of opioids withdrawal symptoms. Intervention 1: Intervention group: Clonidine + Amantadine, clonidine made with "drug manufacturing company" in Iran in 0.2 mg tablets and amantadine capsules made in Iran in Hakim Pharmaceutical Company. clonidine will be used in the same manner in both intervention and placebo groups. Amantadine will start with 100 mg daily and will be increased to 100 mg every 12 hours after one week. And Simultaneously with the cessation of the opioids component it will be increased to 300 mg per day (100 mg every 8 hours) and continues for up to three weeks. Intervention 2: Control group: Clonidine + placebo, clonidine made with "drug manufacturing company" in Iran in 0.2 mg tablets and placebo with similar appearance and taste (prepared in collaboration with Isfahan School of Pharmacy). clonidine will be used in the same manner in both intervention and placebo groups, placebo is also given to patients in the manner of amantadine. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome, can be shared. When: Access range from 1400 To whom: All academic researchers Conditions: Analysis other than those listed in the method and research stage is not allowed. Where to obtain: Correspondence by e-mail How to obtain: Request by e-mail with signature and statement of subject Comments:
public Gholam Reza Kheirabadi
Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 1222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences scientific Gholam Reza Kheirabadi
Behavioral Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 1222 2135 kheirabadi@bsrc.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Satisfaction to participate in the study Having DSM-V criteria for drug dependence Regular and daily consumption of opium and heroin orally, injected or smoked 20 years 60 years Both The patient's unwillingness to continue cooperation Occurrence of any medical or moral conflict with the continued presence of the patient in the study Occurrence of physical and mental problems requires special interventions in the management of opioid withdrawal F11.20 Opioid dependence, uncomplicated Treatment - Drugs Treatment - Drugs Intervention group: Clonidine + Amantadine, clonidine made with "drug manufacturing company" in Iran in 0.2 mg tablets and amantadine capsules made in Iran in Hakim Pharmaceutical Company. clonidine will be used in the same manner in both intervention and placebo groups. Amantadine will start with 100 mg daily and will be increased to 100 mg every 12 hours after one week. And Simultaneously with the cessation of the opioids component it will be increased to 300 mg per day (100 mg every 8 hours) and continues for up to three weeks. Control group: Clonidine + placebo, clonidine made with "drug manufacturing company" in Iran in 0.2 mg tablets and placebo with similar appearance and taste (prepared in collaboration with Isfahan School of Pharmacy). clonidine will be used in the same manner in both intervention and placebo groups, placebo is also given to patients in the manner of amantadine. The effects of amantadine in controlling of opioids withdrawal symptoms. Timepoint: The severity of withdrawal symptoms (initial outcome) on the first day (24 hours after the last dose of the drug) as a baseline assessment and then on days 3, 7, 14 and 21. Method of measurement: SOWS scale. Esfahan University of Medical Sciences Approved 2020-12-14 Isfahan University of Medical Sciences-School of Medicine Hezar Jerib St., Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)