Protocol summary
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Study aim
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compare the efficacy of transcranial Direct Current Stimulation with bupropion in the treatment of nicotine addicts
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Design
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Five arm parallel group randomized sham-controlled trial with blinded participants and outcome assessors.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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).
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Main outcome variables
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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)
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2016-12-25, 1395/10/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research of Shahrud University of Medical Sciences
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Expected recruitment start date
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2016-11-22, 1395/09/02
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Expected recruitment end date
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2017-04-19, 1396/01/30
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Actual recruitment start date
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2016-12-05, 1395/09/15
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Actual recruitment end date
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2017-12-08, 1396/09/17
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Trial completion date
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empty
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Scientific title
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Comparison of the trans-cranial Direct Current Stimulation (tDCS) and Bupropion on treatment of nicotine-dependent smokers.
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Public title
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Effect of transcranial Direct Current Stimulation (tDCS) in cigarette smokers treatment.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 15 years old to 65 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
175
Actual sample size reached:
170
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-26, 1395/05/05
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Ethics committee reference number
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ir.shmu.rec.1395.75
Health conditions studied
1
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Description of health condition studied
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Nicotine dependence in cigarette smokers
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ICD-10 code
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F17.21
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ICD-10 code description
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Nicotine dependence, cigarettes
Primary outcomes
1
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Description
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Salivary Cotinine
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Timepoint
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before intervention, end of intervention, after 6 months
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Method of measurement
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Salivary Cotinine ELISA Kit - Salimetrics
2
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Description
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Fagerstrom Test for Nicotine Dependence
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Timepoint
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before intervention,weekly during intervention,monthly until 6 months follow up
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Method of measurement
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Fagerstrom Questionnaire Completion - Self Declaration
Secondary outcomes
1
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Description
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Craving
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Timepoint
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Befor intervention, weekly during intervention,end of the 6 months follow up.
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Method of measurement
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Tobacco craving questionnaire-short form
2
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Description
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Powerity of brain wave in Quantitative electroencephalogram
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Timepoint
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Befor intervention, weekly during intervention,end of 6 month follow up.
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Method of measurement
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Quantitative electroencephalogram
Intervention groups
1
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Description
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Nicotine Replacement Therapy with 300 mg Bupropione tablet, daily, for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Other
3
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Description
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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).
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Category
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Other
4
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Description
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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
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Category
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Treatment - Other
5
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Description
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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).
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahroud University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available