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IRCT20170822035838N2 IRCT 2018-03-21 پژوهشکده علوم شناختی Studying he long-term Effects of Brain Electrical stimulation on the Rate of Craving and Return to Methamphetamine Consumption Cumulative and Booster Effects of tDCS Sessions on Drug Craving, lapse and Cognitive Impairments in Methamphetamine Users, A Randomized Double Blind Clinical Trial study 2018-04-03 anticipated 60 Complete https://irct.ir/trial/30064 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The statistical population of this study is methamphetamine users. Due to lack of access to all subjects in the population studied, we will sample from consumers who go to Peyrovanehemat Institute for disconnecting the drug. After applying the criteria for entry into the study and basic craving assessment tests, 71 qualified participants are identified. Obviously, at this stage, no choice has taken place, and only 71 first will be selected. The sample size was calculated using the Cochran sampling formula, according to which the maximum sample size for this study was 60. Therefore, 11 of these 71 people should be randomly excluded from the study. In this phase of randomization, the Random allocation rule is used. People are divided into three groups: The first 30 people will enter the intervention group and the second 30 people will go to the control group. The third group containing 11 people are going to be excluded. For this purpose, 71 red and green balls will be placed in a packed dish, and one of the Campus personnel will pick up a ball for each person. The 11 green balls are people who will be excluded. Red balls are numbered from 1 to 60. Couple numbers enter the intervention group and the single numbers will be entered into the control group. In this way, the balls are randomly and without substitution selected for each subject and then the No. and color is registered for the operator. In order to accurately execute the random allocation process and prevent any bias in this study, each stage of the test was conducted by a different person. The researcher tracks 71 entries to the study according to the criteria in the research. Briefly, One of the camp personnel perform the randomization phase (selecting of the balls). Next the operator will execute the test protocol based on the assigned No. to the subjects. Thus, the subjects under study, the camp's personnel and researcher are not aware of the control or intervention groups of subjects, and only the operator knows which subject is in which groups. Inevitably, the researcher is aware of the process of research, but the procedure will be such that the researcher leaves the Camp after the selection of 71 and is not included in the performance of conducting the investigation, Therefore, his data will not ruin the randomization process of the research, Blinding description: This study will be double blind because in this research only the operator of the device is aware of the members of the intervention and control groups and the participants, the camp's employees, and even the self-researcher are unaware of the identity of the participants in each group. Information from volunteers is also entered by another person in a table and analyzed that has no information about the course of the illness. N/A Methamphetamine dependency. Intervention 1: Intervention group: Direct and constant current is generated by a battery and transferred by a pair of 4.5×5 cm (22.5 cm square) electrodes. Electrodes are standard carbonic, covered with a normal saline socked sponge cases. The intervention group receive tDCS for 10 sessions. The anode electrode is placed on right Dorsolateral prefrontal cortex (rDLPFC) and cathode on the forehead above the left eye (Supraorbital) and 2 mA current is passed through patient's brain for 20 min. At the end of the sessions, whenever participants have methamphetamine craving, they will receive one session of tDCS. Intervention 2: Control group: This group will not receive brain stimulation (tDCS). But to create placebo effect, we place the anode and cathode electrodes on the same position as we have done for intervention group. Here there is no brain electric stimulation and the electric current generator is only ramping up to 2 mA in 30 seconds, then gradually ramping down to 0 mA over the period of 1 minute, and then turned off but the electrodes will remain on the scalp for 20 minutes. Of course, subjects will not be informed that the device is turned off. At the end of the sessions, whenever a participant have methamphetamine craving, he will receive this placebo again. Yes - There is a plan to make this available What will be shared: The documentations of this study include reliable questionnaires for assessing the degree of patient craving, useful tests of cognitive assessments, the protocol of working with the device and our proposed methods for following up patients' rehab. All of these, of course will be published after following steps. When: The study is to be published as soon as the analyzes are completed and the results are published in one of the prestigious academic journals. The primary article will include how to sample patients, the correct method of randomization and the implementation of a two-way blind trial, regardless of the results and initial variables. Naturally, there is no possibility of publishing the initial data at this stage, since we want to extracted more results by various analyzes and publish other titles of articles. The remaining data will be publicly available for up to 6 months after the publication of the second article, because the target group of this study is physicians and psychologists working in the field of addiction, and if we want to win their trust, we should provide sufficient documentation for them. To whom: There are no restrictions for applicants Conditions: Raw data would be relatively large since we will have a six-month follow-up a large number of patients with a variety of questionnaires and cognitive tests. Possibly, re-analyzing this information with other statistical methods would be useful. Since the purpose of this study is to extend the use of this device in rehab of the patients, who are trying to discontinue using Met, there is no limit to the review of the method of work and re-analyzing of information and documentation, and the researcher wants to be aware of such meaningful results. Where to obtain: Contacting the researcher or Dr Abharian by e-mail is my suggested method for researchers and enthusiasts, and of course doctors and psychologists who want to learn more about this. How to obtain: Sending a college email is sufficient for the researcher, if not, sending a resume and phone and address to the workplace is necessary for my research team to be able to review the application. Comments:
public Saber Hassanloo
Saleh Charity Clinic - No. 14- Meraj alley - Behesht St.- Khayyam St. - Al-Ayraq - Square of Imam Khomeini
Tehran Iran (Islamic Republic of) 1114785413 +98 21 5580 3121 saberhasanlou@gmail.com Islamic Azad University, South Tehran Branch scientific Dr Peyman Hasani Abharian
Brain and cognition Clinic, No 33, East Zartosht St, Valiassr Square
Tehran Iran (Islamic Republic of) 13950809172385689 +98 21 8880 2063 abharian1972@yahoo.com Brain and Cognition Clinic Iran (Islamic Republic of) 1. Using methamphetamine for at least 6 months as the main drug based on DSM-V2 2. Usage history at least 3 times a week during the last 6 months 3. Male gender 4. Age range of 21-50 years 21 years 50 years Male 1. History of brain damage, epilepsy, brain surgery and tumor F15.2 Other stimulant dependence Rehabilitation Placebo Intervention group: Direct and constant current is generated by a battery and transferred by a pair of 4.5×5 cm (22.5 cm square) electrodes. Electrodes are standard carbonic, covered with a normal saline socked sponge cases. The intervention group receive tDCS for 10 sessions. The anode electrode is placed on right Dorsolateral prefrontal cortex (rDLPFC) and cathode on the forehead above the left eye (Supraorbital) and 2 mA current is passed through patient's brain for 20 min. At the end of the sessions, whenever participants have methamphetamine craving, they will receive one session of tDCS. Control group: This group will not receive brain stimulation (tDCS). But to create placebo effect, we place the anode and cathode electrodes on the same position as we have done for intervention group. Here there is no brain electric stimulation and the electric current generator is only ramping up to 2 mA in 30 seconds, then gradually ramping down to 0 mA over the period of 1 minute, and then turned off but the electrodes will remain on the scalp for 20 minutes. Of course, subjects will not be informed that the device is turned off. At the end of the sessions, whenever a participant have methamphetamine craving, he will receive this placebo again. Basic Met Craving. Timepoint: Before the intervention, 72 hours after the intervention sessions, up to 6 months after the end of the intervention. Method of measurement: Drug Desire Questionnaire (DDQ). Cue-induced craving. Timepoint: Before the intervention, 72 hours after the intervention sessions, up to 6 months after the end of the intervention. Method of measurement: Drug Desire Questionnaire (DDQ). پژوهشکده علوم شناختی Approved 2016-12-31 Ethics committee of Tehran University of Medical Science No 23, Before Poursina Street, Azar 16th street, Keshavarz Boulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)