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IRCT20230306057642N1 IRCT 2023-06-26 Zanjan University of Medical Sciences Evaluation of the therapeutic effect of repetitive Transcranial Magnetic Stimulation (rTMS) on craving in patient with substance dependence Effect of repetitive Transcranial Magnetic Stimulation (rTMS) on craving in patient with substance dependence 2023-07-08 anticipated 36 Complete https://irct.ir/trial/70863 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization: 36 patients will be selected to participate in the study by being available and passing the admission conditions. But assigning them to each treatment group will be simple randomization. For randomization with the help of Excel software by generating binomial distribution and 50% probability for n=36 we produce codes 0 and 1 . In this way, 18 codes 0 and 18 codes 1 are generated equally. Each participant gets a 0 or 1 code completely randomly and with a 50% probability. Code 0 is considered as the control group and code 1 is considered as the intervention group . In this way, the type of treatment for each person is determined before entering the study and observation by each member of the research team. It should be mentioned that due to the double blinding of the study, only the rTMS operator and statistician know how to code and assign patients, Blinding description: The study is double blind. This means that the researcher and the patient do not know the type of treatment. Due to the fact that the treatment can be performed on the patient by the rTMS operator, the double-blind condition can be applied accurately. It should be mentioned that due to the double blinding of the study, only the rTMS operator and statistician know how to code and assign patients. Patients have already read and signed the informed consent form. All patients are connected to the rTMS device, and the cap of the device is placed on their head. No patient is aware of the type of stimulation (active or sham). The rTMS operator knows the type of stimulation. For patients receiving active stimulation, the device is set to 10 Hz. For patients receiving sham stimulation, the device is set to 0 Hz. N/A Substance Use Disorder. Intervention 1: Intervention group: Patients who are treated with active rTMS, receive 12 active rTMS sessions with a frequency of 10 Hz, 3 times a week for 4 consecutive weeks. The cap of the device is placed on the patient's head, and they receive stimulation in the Left Dorsolateral Prefrontal Cortex (Left DLPFC). Intervention 2: Control group: Patients receiving sham stimulation. Patients connect to the rTMS device, and the cap of the device is placed on the Patients head, but they receive sham stimulation. 12 sham rTMS session with a frequency of 0 Hz, 3 times a week for 4 consecutive weeks. Yes - There is a plan to make this available What will be shared: The data can be published after the individuals are not identified. When: When publishing results To whom: Researchers working in academic and scientific institution Conditions: For scientific research Where to obtain: Library of Zanjan University of Medical Sciences How to obtain: Visit the university library Comments:
public Elham Faghih Zadeh
Faculty of Medicine, Karmandan town, Mahdavi Blv
Zanjan Iran (Islamic Republic of) 4513956111 +98 24 3344 0300 e.faghihzadeh@zums.ac.ir Zanjan University of Medical Sciences scientific Mina Shabani
Shahid Beheshti Hospital, Darvazeh Ark, Besat street
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4001 manaz@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patient with diagnosis of Substance Use Disorder (SUD) according to criteria of DSM-5 Absence of multi substance use People should not receive any medicine during the treatment 18 years 60 years Both Simultaneous diagnosis of every other psychiatric illness according to the criteria of DSM-5 Neurological disease such as seizure, stroke, cerebral vascular disease Presence of metal implants, pacemaker, inner ear prothesis Pregnancy Sever physical illness such as infection, malignancy or unstable medical conditions F11.2 Opioid dependence Cannabis dependence Treatment - Other Treatment - Other Intervention group: Patients who are treated with active rTMS, receive 12 active rTMS sessions with a frequency of 10 Hz, 3 times a week for 4 consecutive weeks. The cap of the device is placed on the patient's head, and they receive stimulation in the Left Dorsolateral Prefrontal Cortex (Left DLPFC). Control group: Patients receiving sham stimulation. Patients connect to the rTMS device, and the cap of the device is placed on the Patients head, but they receive sham stimulation. 12 sham rTMS session with a frequency of 0 Hz, 3 times a week for 4 consecutive weeks. Craving in patients with substance use disorder. Timepoint: One day before starting treatment, one day after the end of treatment, two months after the end of treatment. Method of measurement: Desire for Drug Questionnaire (DDQ). Zanjan University of Medical Sciences Approved 2022-11-24 Ethics Committee of Zanjan University of Medical Sciences Dr sobooti Blv Zanjan Zanjan Iran (Islamic Republic of)