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IRCT20200927048850N1 IRCT 2020-10-10 Shahroud University of Medical Sciences Assessing the effect of tDCS on opioid addicts and their brain function Assessing Executive Function and Drug Craving Modulatory Effects of Transcranial Direct Current Stimulation (tDCS) among Opioid Dependents 2020-10-22 anticipated 72 Complete https://irct.ir/trial/51222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, changes in serum BDNF levels are also evaluated, Randomization description: The blocking method is used for randomization in this study. In this method, at first, the block size is determined. Considering the possible loss to follow-up, the sample size is considered to be 72, and considering that we have two groups (R (Real) and (S) Sham, the block size is considered to be 4, and then the list of blocks is written (SRRS). , (SRSR), (SSRR), (RSSR), (RSRS), (RRSS). By writing a program in ٌC ++ language, we create random numbers (numbers between 0 and 51 are considered to be R and numbers between 51 and 100 are considered to be S) and finally we determined the blocks based on the assigned random numbers. We ask the participants to choose a number from 0 to 6. Because we have 6 blocks, we can have 12 people in each block, Blinding description: In this study, data analyst and participants are kept blind to the allocation of study groups. After randomization, the opaque sealed envelope method is used. Researchers and project implementers are not blind to the allocation of study groups. N/A Drug use disorder. Intervention 1: Intervention group: Transcranial Direct Current Stimulation (tDCS) is performed 2 times a day for 5 consecutive days. Stimulation is performed twice in the intervention group for 13 minutes and with 10 minutes interval, 2 mA. Intervention 2: Control group: In this group, Transcranial Direct Current Stimulation (tDCS) at 2 mA is cut off after 30 seconds. This protocol is performed for 5 consecutive days, 2 sessions every day and 13 minutes each session with 10 minutes interval. Yes - There is a plan to make this available What will be shared: All personal data of the participants are shared without a name and personal information (unidentifiable). When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The use of all data or documents for researchers for use in scientific research with reference to the source is allowed. Where to obtain: To the researcher of this study, Roghieh Bahareh Borzooee, refer to the email address b.borzooee@shmu.ac.ir How to obtain: By sending an email to b.borzooee@shmu.ac.ir, the files will be provided to the applicant within 15 days. Comments:
public Roghieh Bahareh Borzooee
Haftom-e Tir Square
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۴۷ +98 23 3239 5054 b.borzooee@shmu.ac.ir Shahroud University of Medical Sciences scientific Shahrokh Aghayan
Haftom-e Tir square
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۴۷ +98 23 3239 5054 aghayan@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Subjects have to be male Subject who is right-handed Subject whose age is between 18 to 55 years At least the fifth elementary education Have opioid dependence criteria based on DSM-5 criteria Have no other psychiatric or neurological illness The main substance consumption have to be opium Do not consume other substances during the project Subject consents to participation in the study and provides a signed informed consent form 18 years 55 years Male Contraindications to tDCS include the presence of any type of cerebral injury in the brain and metal plates on the head, chronic skin problems, severe reactions to tDCS in previous treatments, history of seizures F11.188 Opioid abuse with other opioid-induced disorder Treatment - Other Placebo Intervention group: Transcranial Direct Current Stimulation (tDCS) is performed 2 times a day for 5 consecutive days. Stimulation is performed twice in the intervention group for 13 minutes and with 10 minutes interval, 2 mA. Control group: In this group, Transcranial Direct Current Stimulation (tDCS) at 2 mA is cut off after 30 seconds. This protocol is performed for 5 consecutive days, 2 sessions every day and 13 minutes each session with 10 minutes interval. Rate of changes in baseline substance craving and cue-induced craving. Timepoint: Before the intervention and after the intervention (fifth day) and 2 months later. Method of measurement: Visual Analog Scale, Desire for Drug Questionnaire, Obsessive-Compulsive Drug Use Scale. Serum level changes of Brain-Derived Neurotrophic Factor. Timepoint: Before the intervention and after the intervention (fifth day). Method of measurement: Enzyme-Linked Immunosorbent Assay(ELISA). Evaluation of changes in short-term memory and working memory. Timepoint: Before the intervention and after the intervention (fifth day) and 2 months later. Method of measurement: Forward & Backward Digit span Test. Evaluation of changes in response inhibition and impulsivity. Timepoint: Before the intervention and after the intervention (fifth day) and 2 months later. Method of measurement: Go-No Go Test. Evaluation of changes in decision making and risk-taking. Timepoint: Before the intervention and after the intervention (fifth day) and 2 months later. Method of measurement: Balloon Analog Risk Task (BART). Shahroud University of Medical Sciences Approved 2019-03-11 Ethics Committee of Shahroud University of Medical Sciences Haftom-e Tir Square Shahroud Semnan Iran (Islamic Republic of)