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IRCT20200521047533N1 IRCT 2021-05-24 Shahroud University of Medical Sciences The effect of melatonin on the side effects of methamphetamine The Effect of Melatonin Supplementation on Mental Health, Stem Cells Mobilization and central nervous system function among Methamphetamine Users: Behavioral, Biochemical 2021-05-22 anticipated 46 Complete https://irct.ir/trial/54002 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: In this study, Permuted block randomization is used. I. Randomization type, details of any restrictions (such as blocking and block size) Because patients gradually enter the study and the 4-volume block method is used to make the sample size the same in the two groups. For this purpose, 6 quadruple blocks will be created as follows 1-AABB 2- ABAB 3-ABBA 4-BBAA 5-BABA 6-BAAB Where A is for the intervention group and B is for the control group. The random assignment will be done in such a way that first a random number will be created in Excel from 0 to 9. Depending on which block the random number belongs to, the sequence of that block will be used to assign patients to the control and intervention groups. For example, if the random number generated is 6, the first person will be assigned to group B, the second person to group A, the third person to group A, and the fourth person to group B. To reach the calculated sample size, the random number creation will be repeated 12 times. Because each time the repetition task is assigned, four patients are identified (56 random sequences, each group of 28 people will be produced taking into account the drop). It should be noted that if the random number generated is 7, 8, 9 and 0, it will be ignored. II. Participant allocation concealment method (mechanism used to randomize participant allocation (such as consecutive numbered containers) and explain all the steps that can be taken to hide the sequence until the intervention is assigned to each group) Envelopes in which the specified group is placed are used to conceal the allocation. Envelopes are numbered. After filling in the basic information of the people, an envelope is opened according to the order of entry of the people and the person is assigned to the desired group. That is, 56 envelopes of one shape will be prepared based on the order of A and B above and will be numbered from 1 to 56, respectively. 2 Methamphetamine Addiction. Intervention 1: Intervention group: Participants receive either 10 mg melatonin (2 melatonin capsules, 5 mg each)once a day 1 hour before bedtime for 4 weeks. Intervention 2: Control group: Participants in this group did not receive any medication for 4 weeks due to this study. Yes - There is a plan to make this available What will be shared: Because this project is my graduate dissertation, the results can be published in the dissertation as well as scientific articles and made available to the public. When: 6 months after the publication of dissertations and articles To whom: Scientific research centers and addiction therapists Conditions: Use of data along with mentioning the name of the data collection source and the main researchers Where to obtain: By email and communication with the scientific director of the project How to obtain: After receiving the applicant's email and reviewing it within a maximum of 2 months Comments:
public Ali reza Azizi
No. 57, corner of Khorramshahr, Karun St.
Shahroud Iran (Islamic Republic of) 3613864166 +98 23 3234 8381 alireza.azizi57@yahoo.com Shahroud University of Medical Sciences scientific Hamid Kalalian Moghadam
Alborz Town - Fazlollah Nouri Boulevard - Alborz Building
shahroud Iran (Islamic Republic of) 3717747667 +98 23 3239 2817 H.kalalian@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) have a methamphetamine use history longer than 12 months; Male No history of severe Neurological disease No history of severe Head Trauma Do not take psychiatric drugs now 18 years 55 years Male Having severe psychological illness Having blood diseases F15.1 Other stimulant abuse Treatment - Drugs N/A Intervention group: Participants receive either 10 mg melatonin (2 melatonin capsules, 5 mg each)once a day 1 hour before bedtime for 4 weeks. Control group: Participants in this group did not receive any medication for 4 weeks due to this study. Evaluation of percentage of circulating stem cells in the blood by measuring CD + 34 and CD45 markers. Timepoint: Pre and Post Treatment. Method of measurement: Flow cytometry. Sleep Quality. Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Pittsburgh Sleep Quality Index. Evaluation of patients' depression. Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Beck Depression Inventory. Evaluation of patients' anxiety. Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Beck Anxiety Inventory. Brain-derived neurotrophic factor (BDNF). Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA) kites. Glial fibrillary acidic protein (GFAP). Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA) kites. Measures brain activity by Functional magnetic resonance imaging(fMRI). Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Using Functional magnetic resonance imaging(fMRI). Anatomical study of white matter fibers. Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Using Diffusion tensor imaging (DTI). Investigating changes in Cognitive and functional brain factors such as memory and executive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB). Timepoint: Pre and Post Treatment (beginning of the study and after 28 days of melatonin treatment). Method of measurement: Using the Cambridge Neuropsychological Test Automated Battery(CANTAB). Shahroud University of Medical Sciences Approved 2021-02-07 Shahroud University of Medical Sciences 7 TIR Square shahroud Semnan Iran (Islamic Republic of)