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Protocol summary
This clinical trial study has been designed to comparing effectiveness of Bupropion and transcranial Direct Current Stimulation (tDCS) on nicotine addiction treatment. In this study intervention will be done by a researcher and evaluations will be done by a research assistant and both of them will be unaware of allocation. In order to randomize participants, similar globes equal to the number of participants will be used which have letters A, B, C, D, and E inside of them and represent intervention groups. The number of participants in the study is 175 who will be selected by public announcement among 15-60 year-old, right-handed men who smoke 10 cigarettes a day for at least for one year and are nicotine addicted based on DSM 5 diagnostic criteria. Participants will be allocated to five 35-person experimental groups: 1) 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; 2) Active stimulation as described above which will be done in 5 sessions per week for 2 weeks, and then 1 session per week for 10 weeks; 3 and 4) Sham stimulation groups in which electrodes attachments and stimulation intensity are similar to active stimulation groups except electrical flow will be cut after 30 seconds. 5) Drug treatment group in which 300 mg Bupropion daily will be described for 8 weeks. In this study we will evaluate salivary cotinine levels, craving, severity of dependence and EEG wave power at the beginning and weekly after intervention until six months.
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This clinical trial study has been designed to comparing effectiveness of Bupropion and transcranial Direct Current Stimulation (tDCS) on nicotine addiction treatment. In this study intervention will be done by a researcher and evaluations will be done by a research assistant and both of them will be unaware of allocation. In order to randomize participants, similar globes equal to the number of participants will be used which have letters A, B, C, D, and E inside of them and represent intervention groups. The number of participants in the study is 175 who will be selected by public announcement among 15-60 year-old, right-handed men who smoke 10 cigarettes a day for at least for one year and are nicotine addicted based on DSM 5 diagnostic criteria. Participants will be allocated to five 35-person experimental groups: 1) 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; 2) Active stimulation as described above which will be done in 5 sessions per week for 2 weeks, and then 1 session per week for 10 weeks; 3 and 4) Sham stimulation groups in which electrodes attachments and stimulation intensity are similar to active stimulation groups except electrical flow will be cut after 30 seconds. 5) Drug treatment group in which 300 mg Bupropion daily will be described for 8 weeks. In this study we will evaluate salivary cotinine levels, craving, severity of dependence and EEG wave power at the beginning and weekly after intervention until six months.
این کارازمایی بالینی برای مقایسه اثربخشی بوپروپیون و تحریک جریان مستقیم فراجمجمه ای در درمان اعتیاد به نیکوتین طراحی شده است. نحوه کور کردن این مطالعه به این صورت است که مداخلات توسط پژوهش گر و ارزیابی ها توسط همکار پژوهشی انجام خواهد شد و هم مداخله گر و هم همکار آنالیز کننده بترتیب اطلاعی از نحوه تقسیم بندی افراد و مداخله آنها نخواهند داشت. برای راندومیزه کردن شرکت کنندگان به تعداد آنها از گوی های مشابه استفاده خواهد شد که در داخل آنها از حروف A, B, C, D, E استفاده می شود که نمایانگر گروه های مداخله است. تعداد شرکت کنندگان در این مطالعه 175 نفر است که از طریق فراخوان عمومی از بین مردان 15 تا 60 سال راست دست با حداقل یک سال مصرف روزانه 10 نخ سیگار، انتخاب می شوندکه مطابق معیار های تشخیصی کتاب مرجع روانپزشکی آمریکا (DSM-5) معتاد به نیکوتین بوده باشند. شرکت کنندگان در 5 گروه تجربی 35 نفره قرار می گیرند: 1) تحریک فعال (شامل 20 جلسه تحریک جریان مستقیم فرا جمجمه ای با شدت 2 میلی آمپر و به مدت 20 دقیقه، الکترود آند روی قشر پشتی جانبی پیش پیشانی چپ و الکترود کاتد روی قشر پشتی جانبی پیش پیشانی راست) شامل 5 جلسه تحریک در هر هفته به مدت 4 هفته. 2) تحریک فعال شامل 5 جلسه تحریک در هفته به مدت 2 هفته و سپس یک جلسه در هر هفته به مدت 10 هفته. 3و4 ) گروه های تحریک شم که محل جاگذاری الکترودها و شدت تحریک ها مشایه گروه های اول و دوم است ولی فقط اعمال تحریک بعد از 30 ثانیه قطع می شود. 5) گروه درمان دارویی بوپروپیون با دوز 300 میلی گرم به مدت 8 هفته. در این مطالعه میزان کوتینین بزاق، وسوسه، شدت وابستگی و میزان قدرت دامنه امواج مغزی در بین گروه های مداخله در مدت 6 ماه مقایسه خواهد شد.
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این کارازمایی بالینی برای مقایسه اثربخشی بوپروپیون و تحریک جریان مستقیم فراجمجمه ای در درمان اعتیاد به نیکوتین طراحی شده است. نحوه کور کردن این مطالعه به این صورت است که مداخلات توسط پژوهش گر و ارزیابی ها توسط همکار پژوهشی انجام خواهد شد و هم مداخله گر و هم همکار آنالیز کننده بترتیب اطلاعی از نحوه تقسیم بندی افراد و مداخله آنها نخواهند داشت. برای راندومیزه کردن شرکت کنندگان به تعداد آنها از گوی های مشابه استفاده خواهد شد که در داخل آنها از حروف A, B, C, D, E استفاده می شود که نمایانگر گروه های مداخله است. تعداد شرکت کنندگان در این مطالعه 175 نفر است که از طریق فراخوان عمومی از بین مردان 15 تا 60 سال راست دست با حداقل یک سال مصرف روزانه 10 نخ سیگار، انتخاب می شوندکه مطابق معیار های تشخیصی کتاب مرجع روانپزشکی آمریکا (DSM-5) معتاد به نیکوتین بوده باشند. شرکت کنندگان در 5 گروه تجربی 35 نفره قرار می گیرند: 1) تحریک فعال (شامل 20 جلسه تحریک جریان مستقیم فرا جمجمه ای با شدت 2 میلی آمپر و به مدت 20 دقیقه، الکترود آند روی قشر پشتی جانبی پیش پیشانی چپ و الکترود کاتد روی قشر پشتی جانبی پیش پیشانی راست) شامل 5 جلسه تحریک در هر هفته به مدت 4 هفته. 2) تحریک فعال شامل 5 جلسه تحریک در هفته به مدت 2 هفته و سپس یک جلسه در هر هفته به مدت 10 هفته. 3و4 ) گروه های تحریک شم که محل جاگذاری الکترودها و شدت تحریک ها مشایه گروه های اول و دوم است ولی فقط اعمال تحریک بعد از 30 ثانیه قطع می شود. 5) گروه درمان دارویی بوپروپیون با دوز 300 میلی گرم به مدت 8 هفته. در این مطالعه میزان کوتینین بزاق، وسوسه، شدت وابستگی و میزان قدرت دامنه امواج مغزی در بین گروه های مداخله در مدت 6 ماه مقایسه خواهد شد.
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compare the efficacy of transcranial Direct Current Stimulation with bupropion in the treatment of nicotine addicts
compare the efficacy of transcranial Direct Current Stimulation with bupropion in the treatment of nicotine addicts
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مقایسه اثربخشی تحریک الکتریکی مستقیم فراجمجمه ای متعدد با درمان دارویی بوپروپیون در درمان افراد معتاد به نیکوتین است.
مقایسه اثربخشی تحریک الکتریکی مستقیم فراجمجمه ای متعدد با درمان دارویی بوپروپیون در درمان افراد معتاد به نیکوتین است.
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Five arm parallel group randomized sham-controlled trial with blinded participants and outcome assessors.
Five arm parallel group randomized sham-controlled trial with blinded participants and outcome assessors.
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این مطالعه کارازمایی بالینی تصادفی، پنهان شده، موازی، کور و کنترل با شم است.
این مطالعه کارازمایی بالینی تصادفی، پنهان شده، موازی، کور و کنترل با شم است.
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Bupropion treatment starts at 150 mg for one week, then 300 mg for 8 weeks, and stopping cigarettes will begin in the second week of intervention started. the position of the anode and the cathode in accordance with the standard location of the 20/20, anode is F3, and cathode is F4. The stimulation intensity in the active stimulation group is 2 mA for 20 minutes and in the sham groups is only 30 seconds. The electrodes used in these groups were made of carbon and inside the salt-impregnated sponge with an anode size of 35 and a cathode of 100 centimeters. The outcomes will be measured at the baseline (1), end of interventions (2) and the end of six months of fallow up (3), and point abstinence prevalence will be compared with drug therapy A at this time. The fallow up period is the same for all groups and is 6 months from the start of the intervention.
Bupropion treatment starts at 150 mg for one week, then 300 mg for 8 weeks, and stopping cigarettes will begin in the second week of intervention started. the position of the anode and the cathode in accordance with the standard location of the 20/20, anode is F3, and cathode is F4. The stimulation intensity in the active stimulation group is 2 mA for 20 minutes and in the sham groups is only 30 seconds. The electrodes used in these groups were made of carbon and inside the salt-impregnated sponge with an anode size of 35 and a cathode of 100 centimeters. The outcomes will be measured at the baseline (1), end of interventions (2) and the end of six months of fallow up (3), and point abstinence prevalence will be compared with drug therapy A at this time. The fallow up period is the same for all groups and is 6 months from the start of the intervention.
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درمان دارویی بوپروپیون با دوز 150 میلی گرم برای یک هفته آغاز می شود و سپس 300 میلی گرم برای 8 هفته ادامه می یابد و قطع سیگار از هفته دوم آغاز مداخله خواهد بود. موقعیت قرارگیری آند و کاتد مطابق محل های استاندارد نوار مغزی 20/20 بصورت F3 اندال، F4 کاتدال است. شدت تحریک در گروه تحریک فعال 2 میلی آمپر بمدت 20 دقیقه و در گروه های شم تنها 30 ثانیه خواهد بود. الکترودهای مورد استفاده در این گروه ها از جنس کربنی و داخل اسفنج های آغشته به سرم نمکی بود که اندازه آند 35 و کاتد آن 100سانتی متر مربع می باشد. پیامد ها در مقاطع زمانی baseline( 1)، پایان مداخلات ( 2) و پایان 6 ماه fallow up (3) اندازه گیری خواهد شد و Point abstinence prevalence در این زمانها با درمان دارویی A مقایسه خواهد گردید. مدت fallow up در تمام گروه ها یکسان بوده و 6 ماه از شروع intervention خواهد بود.
درمان دارویی بوپروپیون با دوز 150 میلی گرم برای یک هفته آغاز می شود و سپس 300 میلی گرم برای 8 هفته ادامه می یابد و قطع سیگار از هفته دوم آغاز مداخله خواهد بود. موقعیت قرارگیری آند و کاتد مطابق محل های استاندارد نوار مغزی 20/20 بصورت F3 اندال، F4 کاتدال است. شدت تحریک در گروه تحریک فعال 2 میلی آمپر بمدت 20 دقیقه و در گروه های شم تنها 30 ثانیه خواهد بود. الکترودهای مورد استفاده در این گروه ها از جنس کربنی و داخل اسفنج های آغشته به سرم نمکی بود که اندازه آند 35 و کاتد آن 100سانتی متر مربع می باشد. پیامد ها در مقاطع زمانی baseline( 1)، پایان مداخلات ( 2) و پایان 6 ماه fallow up (3) اندازه گیری خواهد شد و Point abstinence prevalence در این زمانها با درمان دارویی A مقایسه خواهد گردید. مدت fallow up در تمام گروه ها یکسان بوده و 6 ماه از شروع intervention خواهد بود.
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participants of this study select with the public invitation from right-handed 15 - 65 years old smokers, that nicotine addicted according to DSM 5.
participants of this study select with the public invitation from right-handed 15 - 65 years old smokers, that nicotine addicted according to DSM 5.
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شرکت کنندگان این مطالعه از طریق فراخوان عمومی و از بین سیگاری های راست دست 65-15 سال انتخاب می شوند که مطابق معیارهای تشخیصی DSM 5 معتاد به نیکوتین سیگار باشند
شرکت کنندگان این مطالعه از طریق فراخوان عمومی و از بین سیگاری های راست دست 65-15 سال انتخاب می شوند که مطابق معیارهای تشخیصی DSM 5 معتاد به نیکوتین سیگار باشند
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These study interventions included 5 groups: 1) Bupropion medication, 2) Active tDCS (20 sessions/4 weeks), 3) Sham tDCS (20 sessions/4 weeks), 4) Active tDCS (20 sessions/12 weeks) and 5) Sham tDCS (20 sessions/12 weeks).
These study interventions included 5 groups: 1) Bupropion medication, 2) Active tDCS (20 sessions/4 weeks), 3) Sham tDCS (20 sessions/4 weeks), 4) Active tDCS (20 sessions/12 weeks) and 5) Sham tDCS (20 sessions/12 weeks).
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مداخلات این مطالعه شامل 5 گروه می باشد: 1) قرص بوپروپیون 300 میلی گرم برای مدت 8 هفته، 2) تحریک الکتریکی فراجمجمه ای فعال (20 جلسه در 4 هفته)، 3) تحریک الکتریکی کنترل شم (20 جلسه در 4 هفته)، 4) تحریک الکتریکی فراجمجمه ای فعال (20 جلسه در 12 هفته ای) و گروه 5) تحریک الکتریکی کنترل شم (20 جلسه در 12 هفته ای).
مداخلات این مطالعه شامل 5 گروه می باشد: 1) قرص بوپروپیون 300 میلی گرم برای مدت 8 هفته، 2) تحریک الکتریکی فراجمجمه ای فعال (20 جلسه در 4 هفته)، 3) تحریک الکتریکی کنترل شم (20 جلسه در 4 هفته)، 4) تحریک الکتریکی فراجمجمه ای فعال (20 جلسه در 12 هفته ای) و گروه 5) تحریک الکتریکی کنترل شم (20 جلسه در 12 هفته ای).
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the outcomes of this study consist of Salivary Cotinine, Fagerstrom Test of Nicotine Dependence (FTND), Cigarette Per Day (CPD), Tobacco Craving Questionnaire-Short Form and Quantitative Electroencephalogram (QEEG)
the outcomes of this study consist of Salivary Cotinine, Fagerstrom Test of Nicotine Dependence (FTND), Cigarette Per Day (CPD), Tobacco Craving Questionnaire-Short Form and Quantitative Electroencephalogram (QEEG)
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پیامد های مورد مطالعه شامل: کوتینین بزاق، تست شدت وابستگی به نیکوتین فاگرشتروم، تعداد سیگار در روز، پرسشنامه فرم کوتاه وسوسه نیکوتین و نوار مغزی کمی می باشد
پیامد های مورد مطالعه شامل: کوتینین بزاق، تست شدت وابستگی به نیکوتین فاگرشتروم، تعداد سیگار در روز، پرسشنامه فرم کوتاه وسوسه نیکوتین و نوار مغزی کمی می باشد
General information
Not blinded
Triple blinded
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1
1
1
1
1
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170
170
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2016-12-05, 1395/09/15
2016-12-05 00:00:00
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2017-12-08, 1396/09/17
2017-12-08 00:00:00
Comparing the effect of Bupropion and transcranial Direct Current Stimulation on nicotine dependency intensity among addicted cigarette smokers
Effect of transcranial Direct Current Stimulation (tDCS) in cigarette smokers treatment.
Comparing the effectEffect of Bupropion and transcranial Direct Current Stimulation on nicotine dependency intensity among addicted(tDCS) in cigarette smokers treatment.
مقایسه اثر داروی بوپروپیون با تحریک الکتریکی مستقیم فراجمجمه ای در درمان افراد معتاد به سیگار.
اثر تحریک الکتریکی مستقیم فراجمجمه ای در درمان افراد سیگاری
مقایسه اثر داروی بوپروپیون با تحریک الکتریکی مستقیم فراجمجمه ای در درمان افراد معتاد به سیگار.سیگاری
A clinical trial of comparison of the transcranial Direct Current Stimulation (tDCS) and Bupropionon on nicotine dependency intensity among addicted cigarette smokers
Comparison of the trans-cranial Direct Current Stimulation (tDCS) and Bupropion on treatment of nicotine-dependent smokers.
A clinical trial of comparisonComparison of the transcranialtrans-cranial Direct Current Stimulation (tDCS) and BupropiononBupropion on treatment of nicotine dependency intensity among addicted cigarette-dependent smokers.
کارازمایی بالینی مقایسه اثر داروی بوپروپیون و تحریک الکتریکی مستقیم فراجمجمه ای بر شدت وابستگی به نیکوتین در افراد معتاد به سیگار.
مقایسه اثر تحریک الکتریکی مستقیم فراجمجمه ای با داروی بوپروپیون در درمان افراد وابسته به نیکوتین سیگار.
کارازمایی بالینی مقایسه اثر داروی بوپروپیون و تحریک الکتریکی مستقیم فراجمجمه ای بر شدت وابستگیبا داروی بوپروپیون در درمان افراد وابسته به نیکوتین در افراد معتاد به سیگار.
Right-handed, 15 to 65 years old smokers who are nicotine addicted according to DSM-5
Right-handed, 15 to 65 years old smokers who are nicotine addicted according to DSM-5
افراد سیگاری 15 - 65 سال راست دست که مطابق معیار های DSM-5 معتاد به نیکوتین باشند
افراد سیگاری 15 - 65 سال راست دست که مطابق معیار های DSM-5 معتاد به نیکوتین باشند
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
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
مصرف سایر مواد (هرویین، آمفتامین، حشیش)
وجود بیماری های روانپزشکی (افسردگی، اختلال دوطبی و...)
وجود بیماری های جسمانی (تومور مغزی، حملات تشنجی و ...)
مصرف داروهای حاوی کلسیم، سدیم، پتاسیم
مصرف سایر محصولات تنباکو مانند چپق و قلیان
مصرف سایر مواد (هرویین، آمفتامین، حشیش) وجود بیماری های روانپزشکی (افسردگی، اختلال دوطبی و...) وجود بیماری های جسمانی (تومور مغزی، حملات تشنجی و ...) مصرف داروهای حاوی کلسیم، سدیم، پتاسیم مصرف سایر محصولات تنباکو مانند چپق و قلیان
This study no blinded but individuals that analysis and interfere will be different. the purpose of placebo in this study is the sham.
This study no blinded but individuals that analysis and interfere will be different. the purpose of placebo in this study is the sham.
این مطالعه کور نشده ولی فرد مداخله گر و فرد آنالیزور متفاوت خواهند بود .
منظور اتز دارونما در این مطالعه همان مداخله sham می باشد
این مطالعه کور نشده ولی فرد مداخله گر و فرد آنالیزور متفاوت خواهند بود . منظور اتز دارونما در این مطالعه همان مداخله sham می باشد
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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.
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.
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در این مطالعه برای ایجاد توالی تصادفی، از تصادفی سازی محدود به روش قانون تخصیص تصادفی، توسط گوی های مشابه استفاده شد که توسط گروه آنالیزور تیم تحقیق طراحی شد. برای پنهان سازی تخصیص تصادفی از پاکت نامه های غیر شفاف مهر و موم شده با توالی تصادفی استفاده شد که در پذیرش مرکز تحقیق ما نگهداری و توسط ایشان اجرا گردید و بدین ترتیب شرکت کنندگان در گروه های خود تخصیص یافتند.
در این مطالعه برای ایجاد توالی تصادفی، از تصادفی سازی محدود به روش قانون تخصیص تصادفی، توسط گوی های مشابه استفاده شد که توسط گروه آنالیزور تیم تحقیق طراحی شد. برای پنهان سازی تخصیص تصادفی از پاکت نامه های غیر شفاف مهر و موم شده با توالی تصادفی استفاده شد که در پذیرش مرکز تحقیق ما نگهداری و توسط ایشان اجرا گردید و بدین ترتیب شرکت کنندگان در گروه های خود تخصیص یافتند.
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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.
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.
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نحوه blind کردن این مطالعه به این صورت بود که کلیه مداخلات توسط محقق و آزمایش ها، ثبت نتایج و آنالیز آنها توسط سایر همکاران پژوهشی انجام گردید. بطوریکه فرد مداخله گر از نتایج مداخلات، و سایر همکاران پژوهشی از نوع مداخلات هر گروه بی اطلاع بودند.
نحوه blind کردن این مطالعه به این صورت بود که کلیه مداخلات توسط محقق و آزمایش ها، ثبت نتایج و آنالیز آنها توسط سایر همکاران پژوهشی انجام گردید. بطوریکه فرد مداخله گر از نتایج مداخلات، و سایر همکاران پژوهشی از نوع مداخلات هر گروه بی اطلاع بودند.
Health conditions studied
#1
F17.21
F17.21
Nicotine dependence, cigarettes
Nicotine dependence, cigarettes
Nicotine addiction treatment
Nicotine dependence in cigarette smokers
Nicotine addiction treatmentdependence in cigarette smokers
QuestionnaieTobacco craving questionnaire-short form
پرسشنامه
فرم کوتاه پرسشنامه وسوسه تنباکو
فرم کوتاه پرسشنامه وسوسه تنباکو
#2
Quantitative electroencephalogram
Powerity of brain wave in Quantitative electroencephalogram
Powerity of brain wave in Quantitative electroencephalogram
دامنه امواج مغزی
دامنه امواج مغزی در الکتروانسفالوگرافی کیفی مغزی
دامنه امواج مغزی در الکتروانسفالوگرافی کیفی مغزی
Power of QEEG
Quantitative electroencephalogram
Power of QEEGQuantitative electroencephalogram
ثبت نوار مغزی
نوار مغزی کیفی
ثبت نوار مغزی کیفی
Intervention groups
#1
Other
Treatment - Other
treatment-other
#2
Other
Treatment - Other
treatment-other
#3
Treatment - Other
Other
treatment-other
Recruitment centers
#1
Name of recruitment center - English: Public invitation
Name of recruitment center - Persian: فراخوان عمومی
Full name of responsible person - English:
Full name of responsible person - Persian:
Street address - English:
Street address - Persian:
City - English: Shahroud
City - Persian: شاهرود
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Center of health related social and Behavioural science research, Shahroud University of Medical Sci
Name of recruitment center - Persian: مرکز تحقیقات علوم رفتاری و بهداشت اجتماعی، دانشگاه علوم پزشکی شاهرود
Full name of responsible person - English: Seyed Mohammad Mirrezaie
Full name of responsible person - Persian: سید محمد میررضایی
Street address - English: Haft Tir Square, Shahroud University of Medical Sciences
Street address - Persian: میدان هفت تیر دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3614773947
Phone: +98 23 3239 4091
Fax: +98 23 3239 5009
Email: Mirrezaie@shmu.ac.ir
Web page address:
Name of recruitment center - English: Public invitationCenter of health related social and Behavioural science research, Shahroud University of Medical Sci Name of recruitment center - Persian: فراخوان عمومیمرکز تحقیقات علوم رفتاری و بهداشت اجتماعی، دانشگاه علوم پزشکی شاهرود Full name of responsible person - English: Seyed Mohammad Mirrezaie Full name of responsible person - Persian: سید محمد میررضایی Street address - English: Haft Tir Square, Shahroud University of Medical Sciences Street address - Persian: میدان هفت تیر دانشگاه علوم پزشکی شاهرود City - English: Shahroud City - Persian: شاهرود Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3614773947 Phone: +98 23 3239 4091 Fax: +98 23 3239 5009 Email: Mirrezaie@shmu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Shahroud University of Medical Science
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شاهرود
Full name of responsible person - English: Shahram Ghorbani Behnam
Full name of responsible person - Persian: شهرام قربانی بهنام
Street address - English: Shahroud University of Medical Sciences, Haftetir square
Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Hassan Emamian
Full name of responsible person - Persian: محمد حسن امامیان
Street address - English: Shahroud University of Medical Sciences, Haft Tir Square
Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3624773955
Phone: +98 23 3239 4499
Fax:
Email: emamian@shmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Shahroud University of Medical Science Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شاهرود Full name of responsible person - English: Shahram Ghorbani BehnamMohammad Hassan Emamian Full name of responsible person - Persian: شهرام قربانی بهناممحمد حسن امامیان Street address - English: Shahroud University of Medical Sciences, Haftetir squareHaft Tir Square Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود City - English: Shahroud City - Persian: شاهرود Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3624773955 Phone: +98 23 3239 4499 Fax: Email: emamian@shmu.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice chancellor for research, Shahroud University of Medical Science
Shahroud University of Medical Sciences
Vice chancellor for research, Shahroud University of Medical ScienceSciences
معاونت پژوهشی دانشگاه علوم پزشکی شاهرود
دانشگاه علوم پزشکی شاهرود
معاونت پژوهشی دانشگاه علوم پزشکی شاهرود
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Shahroud University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود
Full name of responsible person - English: Shahram Ghorbani Behnam
Full name of responsible person - Persian: شهرام قربانی بهنام
Position - English: PhD Candidate
Position - Persian: دانشجوی دکتری تخصصی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahroud University of Medical Sciences, Haftetir square
Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 23 3239 5062
Mobile: +98 933 329 6393
Fax:
Email: ghorbani@shmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shahram Ghorbani Behnam
Full name of responsible person - Persian: شهرام قربانی بهنام
Position - English: MD
Position - Persian: پزشک
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 1, Shahroud Univercity of Medical Science , Haftetir square
Street address - Persian: میدان هفت تیر، پلاک 1، دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province: Semnan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3624773955
Phone: +98 23 3239 5003
Mobile: +98 914 311 8290
Fax: +98 23 3239 5003
Email: ghorbani@shmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shahroud University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود Full name of responsible person - English: Shahram Ghorbani Behnam Full name of responsible person - Persian: شهرام قربانی بهنام Position - English: PhD CandidateMD Position - Persian: دانشجوی دکتری تخصصیپزشک Latest degree: med_doctor Area of specialty/work: 030 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 1, Shahroud UniversityUnivercity of Medical SciencesScience , Haftetir square Street address - Persian: میدان هفت تیر، پلاک 1، دانشگاه علوم پزشکی شاهرود City - English: Shahroud City - Persian: شاهرود Province: Semnan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3624773955 Phone: +98 23 3239 50625003 Mobile: +98 933 329 6393914 311 8290 Fax: +98 23 3239 5003 Email: ghorbani@shmu.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Shahroud University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود
Full name of responsible person - English: Dr Seyyed Abbas Musavi
Full name of responsible person - Persian: دکتر سید عباس موسوی
Position - English: Associate Pofessore
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahroud University of Medical Sciences, Haftetir square
Street address - Persian: دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 23 3239 5062
Mobile: +98 912 173 5519
Fax:
Email: mmm89099@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Abbas Mousavi
Full name of responsible person - Persian: سید عباس موسوی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 47
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahroud University of Medical Sciences, Haftetir square
Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province: Semnan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3624773955
Phone: +98 23 3239 5062
Mobile: +98 912 173 5519
Fax:
Email: mmm89099@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahroud University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود Full name of responsible person - English: Dr SeyyedSeyed Abbas MusaviMousavi Full name of responsible person - Persian: دکتر سید عباس موسوی Position - English: Associate PofessoreAssistant Professor Position - Persian: دانشیاراستادیار Latest degree: specialist Area of specialty/work: 047 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahroud University of Medical Sciences, Haftetir square Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود City - English: Shahroud City - Persian: شاهرود Province: Semnan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3624773955 Phone: +98 23 3239 5062 Mobile: +98 912 173 5519 Fax: Email: mmm89099@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Shahroud University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود
Full name of responsible person - English: Shahram Ghorbani Behnam
Full name of responsible person - Persian: شهرام قربانی بهنام
Position - English: PhD candidate
Position - Persian: دانشجو دکترای تخصصی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahroud University of Medical Sciences, Haftetir square
Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرود
City - English: Shahroud
City - Persian: شاهرود
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 23 3239 5062
Mobile: +98 933 329 6393
Fax:
Email: ghorbani@shmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shahram Ghorbani Behnam
Full name of responsible person - Persian: شهرام قربانی بهنام
Position - English: MD
Position - Persian: پزشک
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 1, Haftetir square
Street address - Persian: میدان هفت تیر، پلاک ۱
City - English: Shahroud
City - Persian: شاهرود
Province: Semnan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3624773955
Phone: +98 23 3239 5003
Mobile: +98 914 311 8290
Fax: +98 23 3239 5003
Email: ghorbani@shmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shahroud University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شاهرود Full name of responsible person - English: Shahram Ghorbani Behnam Full name of responsible person - Persian: شهرام قربانی بهنام Position - English: PhD candidateMD Position - Persian: دانشجو دکترای تخصصیپزشک Latest degree: med_doctor Area of specialty/work: 030 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahroud University of Medical SciencesNo 1, Haftetir square Street address - Persian: میدان هفت تیر، دانشگاه علوم پزشکی شاهرودپلاک ۱ City - English: Shahroud City - Persian: شاهرود Province: Semnan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3624773955 Phone: +98 23 3239 50625003 Mobile: +98 933 329 6393914 311 8290 Fax: +98 23 3239 5003 Email: ghorbani@shmu.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
After the study is completed will be done
After the study is completed will be done
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بعد از پایان مطالعه انجام خواهد شد
بعد از پایان مطالعه انجام خواهد شد
Protocol summary
Study aim
compare the efficacy of transcranial Direct Current Stimulation with bupropion in the treatment of nicotine addicts
Design
Five arm parallel group randomized sham-controlled trial with blinded participants and outcome assessors.
Settings and conduct
Bupropion treatment starts at 150 mg for one week, then 300 mg for 8 weeks, and stopping cigarettes will begin in the second week of intervention started. the position of the anode and the cathode in accordance with the standard location of the 20/20, anode is F3, and cathode is F4. The stimulation intensity in the active stimulation group is 2 mA for 20 minutes and in the sham groups is only 30 seconds. The electrodes used in these groups were made of carbon and inside the salt-impregnated sponge with an anode size of 35 and a cathode of 100 centimeters. The outcomes will be measured at the baseline (1), end of interventions (2) and the end of six months of fallow up (3), and point abstinence prevalence will be compared with drug therapy A at this time. The fallow up period is the same for all groups and is 6 months from the start of the intervention.
Participants/Inclusion and exclusion criteria
participants of this study select with the public invitation from right-handed 15 - 65 years old smokers, that nicotine addicted according to DSM 5.
Intervention groups
These study interventions included 5 groups: 1) Bupropion medication, 2) Active tDCS (20 sessions/4 weeks), 3) Sham tDCS (20 sessions/4 weeks), 4) Active tDCS (20 sessions/12 weeks) and 5) Sham tDCS (20 sessions/12 weeks).
Main outcome variables
the outcomes of this study consist of Salivary Cotinine, Fagerstrom Test of Nicotine Dependence (FTND), Cigarette Per Day (CPD), Tobacco Craving Questionnaire-Short Form and Quantitative Electroencephalogram (QEEG)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2016072629093N1
Registration date:2016-12-25, 1395/10/05
Registration timing:registered_while_recruiting
Last update:2018-06-18, 1397/03/28
Update count:1
Registration date
2016-12-25, 1395/10/05
Registrant information
Name
Shahram Ghorbani Behnam
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5003
Email address
ghorbani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahrud University of Medical Sciences
Expected recruitment start date
2016-11-22, 1395/09/02
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
2016-12-05, 1395/09/15
Actual recruitment end date
2017-12-08, 1396/09/17
Trial completion date
empty
Scientific title
Comparison of the trans-cranial Direct Current Stimulation (tDCS) and Bupropion on treatment of nicotine-dependent smokers.
Public title
Effect of transcranial Direct Current Stimulation (tDCS) in cigarette smokers treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Right-handed, 15 to 65 years old smokers who are nicotine addicted according to DSM-5
Exclusion criteria:
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
Age
From 15 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
175
Actual sample size reached:
170
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrud Medical University
Street address
Shahroud University of Medical Sciences, Haftetir square
City
Shahroud
Province
Semnan
Postal code
3624773955
Approval date
2016-07-26, 1395/05/05
Ethics committee reference number
ir.shmu.rec.1395.75
Health conditions studied
1
Description of health condition studied
Nicotine dependence in cigarette smokers
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes
Primary outcomes
1
Description
Salivary Cotinine
Timepoint
before intervention, end of intervention, after 6 months
Method of measurement
Salivary Cotinine ELISA Kit - Salimetrics
2
Description
Fagerstrom Test for Nicotine Dependence
Timepoint
before intervention,weekly during intervention,monthly until 6 months follow up
Befor intervention, weekly during intervention,end of the 6 months follow up.
Method of measurement
Tobacco craving questionnaire-short form
2
Description
Powerity of brain wave in Quantitative electroencephalogram
Timepoint
Befor intervention, weekly during intervention,end of 6 month follow up.
Method of measurement
Quantitative electroencephalogram
Intervention groups
1
Description
Nicotine Replacement Therapy with 300 mg Bupropione tablet, daily, for 8 weeks.
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Other
3
Description
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).
Category
Other
4
Description
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
Category
Treatment - Other
5
Description
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).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of health related social and Behavioural science research, Shahroud University of Medical Sci
Full name of responsible person
Seyed Mohammad Mirrezaie
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 4091
Fax
+98 23 3239 5009
Email
Mirrezaie@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3624773955
Phone
+98 23 3239 4499
Fax
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahram Ghorbani Behnam
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 1, Shahroud Univercity of Medical Science , Haftetir square
City
Shahroud
Province
Semnan
Postal code
3624773955
Phone
+98 23 3239 5003
Fax
+98 23 3239 5003
Email
ghorbani@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyed Abbas Mousavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahroud University of Medical Sciences, Haftetir square
City
Shahroud
Province
Semnan
Postal code
3624773955
Phone
+98 23 3239 5062
Fax
Email
mmm89099@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahram Ghorbani Behnam
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 1, Haftetir square
City
Shahroud
Province
Semnan
Postal code
3624773955
Phone
+98 23 3239 5003
Fax
+98 23 3239 5003
Email
ghorbani@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available