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IRCT2016072629093N1 IRCT 2016-12-25 Shahroud University of Medical Sciences Effect of transcranial Direct Current Stimulation (tDCS) in cigarette smokers treatment. Comparison of the trans-cranial Direct Current Stimulation (tDCS) and Bupropion on treatment of nicotine-dependent smokers. 2016-11-22 anticipated 175 Complete https://irct.ir/trial/23472 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, for random sequencing generation, random allocation rule from restricted randomization with similar spheres was done , witch designed by a team of analyzers of the research group. In order to allocation concealment sequentially numbered, sealed, opaque envelops were used that were kept by our research center reception and were implemented by them, and thus, participants were assigned in their groups, Blinding description: The method of the blindness of this study was that all interventions were performed by the researcher and carried out tests, recorded results and analyzed by other research partners. So that the intervener was unaware of the outcome of the interventions, and other research partners were unaware of the types of interventions of each group. N/A Nicotine dependence in cigarette smokers. Intervention 1: Nicotine Replacement Therapy with 300 mg Bupropione tablet, daily, for 8 weeks. Intervention 2: Active stimulation (transcranial Direct Current Stimulation with 2 mA amplitudes for 20 minutes, anode will be attached on left DLPFC (dorsolateral prefrontal cortex) and cathode will be attached on right DLPFC) for 20 sessions consisted of 5 sessions per week for 4 weeks. Intervention 3: Twenty sessions sham transcranial Direct Current Stimulation (in which electrodes attachments and stimulation intensity are similar to active stimulation groups except electrical flow will be cut after 30 seconds) with 2 mA for30 seconds, anode on left and cathode on right DLPFC (5 sessions per week for 4 weeks). Intervention 4: Active stimulation (transcranial Direct Current Stimulation with 2 mA amplitudes for 20 minutes, anode will be attached on left DLPFC (dorsolateral prefrontal cortex) and cathode will be attached on right DLPFC) which will be done in 5 sessions per week for 2 weeks, and then 1 session per week for 10 weeks. Intervention 5: Twenty sessions sham transcranial Direct Current Stimulation (in which electrodes attachments and stimulation intensity are similar to active stimulation groups except electrical flow will be cut after 30 seconds) with 2 mA for 30 seconds, anode on left and cathode on right DLPFC (5 sessions per week for 2 weeks, and then 1 session per week for 10 weeks). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the study is completed will be done
public Shahram Ghorbani Behnam
No 1, Shahroud Univercity of Medical Science , Haftetir square
Shahroud Iran (Islamic Republic of) 3624773955 +98 23 3239 5003 ghorbani@shmu.ac.ir Shahroud University of Medical Sciences scientific Seyed Abbas Mousavi
Shahroud University of Medical Sciences, Haftetir square
Shahroud Iran (Islamic Republic of) 3624773955 +98 23 3239 5062 mmm89099@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Right-handed, 15 to 65 years old smokers who are nicotine addicted according to DSM-5 15 years 65 years Male Other substances use (heroin, amphetamines, cannabis) psychiatric diseases (Depression, Bipolar Mood Disorders, ...) physical disease (brain tumors, seizure attacks, ...) drug use containing calcium, sodium, potassium Other tobacco use, such as chops and hookahs F17.21 Nicotine dependence, cigarettes Treatment - Drugs Treatment - Other Other Treatment - Other Other Nicotine Replacement Therapy with 300 mg Bupropione tablet, daily, for 8 weeks. Active stimulation (transcranial Direct Current Stimulation with 2 mA amplitudes for 20 minutes, anode will be attached on left DLPFC (dorsolateral prefrontal cortex) and cathode will be attached on right DLPFC) for 20 sessions consisted of 5 sessions per week for 4 weeks Twenty sessions sham transcranial Direct Current Stimulation (in which electrodes attachments and stimulation intensity are similar to active stimulation groups except electrical flow will be cut after 30 seconds) with 2 mA for30 seconds, anode on left and cathode on right DLPFC (5 sessions per week for 4 weeks). Active stimulation (transcranial Direct Current Stimulation with 2 mA amplitudes for 20 minutes, anode will be attached on left DLPFC (dorsolateral prefrontal cortex) and cathode will be attached on right DLPFC) which will be done in 5 sessions per week for 2 weeks, and then 1 session per week for 10 weeks Twenty sessions sham transcranial Direct Current Stimulation (in which electrodes attachments and stimulation intensity are similar to active stimulation groups except electrical flow will be cut after 30 seconds) with 2 mA for 30 seconds, anode on left and cathode on right DLPFC (5 sessions per week for 2 weeks, and then 1 session per week for 10 weeks). Salivary Cotinine. Timepoint: before intervention, end of intervention, after 6 months. Method of measurement: Salivary Cotinine ELISA Kit - Salimetrics. Fagerstrom Test for Nicotine Dependence. Timepoint: before intervention,weekly during intervention,monthly until 6 months follow up. Method of measurement: Fagerstrom Questionnaire Completion - Self Declaration. Craving. Timepoint: Befor intervention, weekly during intervention,end of the 6 months follow up. Method of measurement: Tobacco craving questionnaire-short form. Powerity of brain wave in Quantitative electroencephalogram. Timepoint: Befor intervention, weekly during intervention,end of 6 month follow up. Method of measurement: Quantitative electroencephalogram. Shahroud University of Medical Sciences Approved 2016-07-26 Ethics committee of Shahrud Medical University Shahroud University of Medical Sciences, Haftetir square Shahroud Semnan Iran (Islamic Republic of)