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IRCT20201214049718N1 IRCT 2021-01-25 Esfahan University of Medical Sciences The effect of melatonin on sleep quality, mental health and performance in patients with drug abuse in methadone-treated patients The effect of melatonin on sleep quality, mental health and performance in patients with drug abuse in methadone-treated patients 2021-01-20 anticipated 105 Complete https://irct.ir/trial/53047 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization process is a simple randomization method using Random allocation software . We list the people who have the inclusion criteria and consent to participate in the study according to the three digits to the right of the national code from 1 to 105 and then using Random allocation software is divided into three groups a: Melatonin, group b: Zolpidem, group c: control. In front of each number, the assigned group is created, Blinding description: Responsible for collecting questionnaire information and analyzing statistics will be unaware of the placement of people in groups. Coding of people is done based on the first name and surname and father's name and the last three digits of the national code. Does not know about the assignment of individuals in groups, will give the questionnaires to the participants before and one month after the start of the study and enters the data into SPSS and this data will be analyzed by the analyzer if it is not in the coding process. 3 Patients with drug abuse, people treated with methadone. Intervention 1: Intervention group 1: In this group, patients will use three 3 mg melatonin tablets made by Razak company half an hour before bedtime for 4 weeks. In addition to melatonin, these patients receive methadone syrup made by Darou Pakhsh Company in the morning and evening (4 hours before bedtime) according to the required dose for 4 weeks. Intervention 2: intervention group 2: In this group, patients will take a 10 mg zolpidem tablet made by Sobhan Company for 4 weeks before bedtime. In addition to zolpidem, these patients receive methadone syrup made by Darou Pakhsh Company in the morning and evening (4 hours before bedtime) according to the required dose for 4 weeks. Intervention 3: Control group: In this group, patients will take a capsule filled with starch as placebo for 4 weeks at night before bedtime. In addition to placebo, these patients will receive methadone syrup made by Darou Pakhsh Company in the morning and evening (4 hours before bedtime) according to the required dose for 4 weeks. Yes - There is a plan to make this available What will be shared: Total potential data is shareable after unre identifying people When: Starting access period 6 months after printing results To whom: It will be available for researchers working in academic and scientific institutions, as well as those working in the industry Conditions: Use in other articles Where to obtain: zahraamini63@gmail.com How to obtain: After reading the e-mail and preparing the request answer, the answer will be given as soon as possible Comments:
public Zahra Amini
Preventive & Community Medicine Community Medicin Department Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3274 7970 zahraamini63@gmail.com Esfahan University of Medical Sciences scientific Zahra Amini
Preventive & Community Medicin Community Medicine Department Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3274 7970 zahraamini63@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in research Over 18 years of age Having writing literacy Substance abuse confirmed by positive urine tests PSQI score above 5 No neurological, neuro-psychotic or autoimmune disease, cancer, lung disease, class 4 heart failure or unstable angina No taking benzodiazepines, anticonvulsants, aspirin, beta-blockers, calcium channel blockers, NSAIDs, dexamethasone, lithium, melatonin, and antidepressants such as serotonin reuptake inhibitors. Not working in night shift Taking methadone for at least 3 months 18 years no limit Both If there is a crisis or un foreseeable disaster during the research. Changes in treatment protocol for any reason before the intervention Sever allergic reaction to melatonin and zolpidem Pregnancy or Lactation Z71.5 Drug abuse counseling and surveillance Rehabilitation Rehabilitation Rehabilitation Intervention group 1: In this group, patients will use three 3 mg melatonin tablets made by Razak company half an hour before bedtime for 4 weeks. In addition to melatonin, these patients receive methadone syrup made by Darou Pakhsh Company in the morning and evening (4 hours before bedtime) according to the required dose for 4 weeks. intervention group 2: In this group, patients will take a 10 mg zolpidem tablet made by Sobhan Company for 4 weeks before bedtime. In addition to zolpidem, these patients receive methadone syrup made by Darou Pakhsh Company in the morning and evening (4 hours before bedtime) according to the required dose for 4 weeks. Control group: In this group, patients will take a capsule filled with starch as placebo for 4 weeks at night before bedtime. In addition to placebo, these patients will receive methadone syrup made by Darou Pakhsh Company in the morning and evening (4 hours before bedtime) according to the required dose for 4 weeks. Sleep Quality Score in Petzburg Sleep Quality Questionnaire. Timepoint: Before and 4 weeks after intervention. Method of measurement: Petzburg Sleep Quality Questionnaire. Mental health score in Depression, Anxiety, Stress Scale-21. Timepoint: Before and 4 weeks after intervention. Method of measurement: Depression, Anxiety, Stress Scale-21. Sexual function score in Internation Index of Erectile Function Questionnaire. Timepoint: Before and 4 weeks after intervention. Method of measurement: Internation Index of Erectile Function Questionnaire. General health score in General Health Questionnaire-28. Timepoint: Measurement of general health score before the intervention and 4 weeks after the taking of melatonin or zolpidem or placebo. Method of measurement: General Health Questionnaire-28. Esfahan University of Medical Sciences Approved 2020-12-12 Ethics committee of Isfahan University of Medical Sciences Building 56, No. 6, Khaju St Isfahan Isfehan Iran (Islamic Republic of)