A clinical trial of comparison of the transcranial Direct Current Stimulation (tDCS) and Bupropionon on nicotine dependency intensity among addicted cigarette smokers
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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072629093N1
Registration date:2016-12-25, 1395/10/05
Registration timing:registered_while_recruiting
Last update:
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of comparison of the transcranial Direct Current Stimulation (tDCS) and Bupropionon on nicotine dependency intensity among addicted cigarette smokers
Public title
Comparing the effect of Bupropion and transcranial Direct Current Stimulation on nicotine dependency intensity among addicted cigarette smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:" Right handed cigarette addicted male; age between 15 - 65 years old.
Exclusion criteria:Other substance use; Other Psychiatric or Physical disease; Any drug use that contain Mg, Ca, Na; Use of other tobacco products such as shisha, pipe... .
Age
From 15 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
175
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study no blinded but individuals that analysis and interfere will be different. the purpose of placebo in this study is the sham.
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
Postal code
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 addiction treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
nicotine addiction intensity
Timepoint
before intervention, end of intervention, after 6 months
Method of measurement
Fagerstrom questionnaire
2
Description
Saliva cotinine
Timepoint
before intervention,weekly during intervention,monthly until 6 months follow up
Method of measurement
ELISA Test
Secondary outcomes
1
Description
Craving
Timepoint
Befor intervention, weekly during intervention,end of the 6 months follow up.
Method of measurement
Questionnaie
2
Description
Quantitative electroencephalogram
Timepoint
Befor intervention, weekly during intervention,end of 6 month follow up.
Method of measurement
Power of QEEG
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
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
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
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Public invitation
Full name of responsible person
Street address
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Science
Full name of responsible person
Shahram Ghorbani Behnam
Street address
Shahroud University of Medical Sciences, Haftetir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahroud University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahram Ghorbani Behnam
Position
PhD Candidate
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftetir square
City
Shahroud
Postal code
Phone
+98 23 3239 5062
Fax
Email
ghorbani@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Seyyed Abbas Musavi
Position
Associate Pofessore
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftetir square
City
Shahroud
Postal code
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
PhD candidate
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftetir square
City
Shahroud
Postal code
Phone
+98 23 3239 5062
Fax
Email
ghorbani@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)