Effects of Transcranial Direct Current Stimulation on Tobacco Withdrawal Symptoms (tDCSsmokers)
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| First Received Date ICMJE | March 28, 2012 | ||||
| Last Updated Date | April 15, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01567982 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Reaction time on an attention task [ Time Frame: 20 minutes ] [ Designated as safety issue: No ] Participants will perform a computerized visual attention task. Performance measures including reaction time and accuracy. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Transcranial Direct Current Stimulation on Tobacco Withdrawal Symptoms | ||||
| Official Title ICMJE | Phase 1 Study of Effects of tDCS on Tobacco Withdrawal Symptoms | ||||
| Brief Summary | We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours. |
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| Detailed Description | We will recruit 35 non-smokers and 30 adult smokers who smoke > 15 cigarettes/day for more than two years and are 18-55 years old. We expect about half of them will be females. All participants will be screened for drugs of abuse and female participants will receive a pregnancy test. Each smoker will participate in four tDCS sessions, one for sham and three for real tDCS, each for one set of electrode montage. The first set is dorsal lateral prefrontal cortex (i.e., F3 and F4 of 10/20 EEG system) and neck. The second set is middle line prefrontal cortex (Fz), superior parietal cortex (Pz), and bilateral inferior temporal cortex (T3 and T4). The third set is left dorsal lateral prefrontal cortex (F3) and superior parietal cortex (P1), and right inferior temporal cortex (T4). The sequence of real and sham tDCS will be counterbalanced among participants. Each session will last for 20 minutes and there will be a minimum 48 hours between the two sessions. Participants will be required to be abstinent from cigarette smoking overnight for a minimum of 10 hours and arrive at our lab around 8:30 AM for each tDCS session. After arrival, each participant will provide a breath sample for detection of any alcohol in their system, an assay of CO and for verification of abstinence from cigarette smoking. We will place a nicotine patch (Nicoderm with 21 mg nicotine) on the back of participants. We will also ask each participant to chew a nicotine gum (Nicorette gum with 4 mg nicotine) for 30 minutes. The participants will perform a battery of computerized tasks including the N-Back working memory task, and an attention task involving watching a computer screen and pressing buttons to indicate more odd or even numbers displayed on the screen. In addition participants will complete the following questionnaires related to mood, nicotine withdrawal, mental state, possible side effects, and cigarette craving: Profile of Mood States (McNair et al 1971), Shiffman-Jarvik Withdrawal Scales (Shiffman & Jarvik 1976), and Urge To Smoke (Jarvik et al 2000), tDCS side effects questionnaire, Wisconsin Smoking Withdrawal Scale (Welsch 1999), Perceived Stress Scale (Cohen 1983), Spielberger State/Trait Anxiety Questionnaire (Spielberger 1970). Each participant will repeat above battery of cognitive tasks and questionnaires after tDCS. Then they will be instructed to smoke one cigarette after this second battery of tasks/questionnaires, and repeat the second battery of questionnaires after cigarette smoking. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Device: tDCS, prefrontal cortex and parietal cortex
tDCS is a non invasive brain stimulation methods. We will use two anodes to stimulate prefrontal and/or parietal cortex using 2mA current for 20 minutes.
Other Name: transcranial direct current stimulation |
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| Study Arm (s) | Experimental: smokers and nonsmokers
both smokers and nonsmokers will receive same tDCS
Intervention: Device: tDCS, prefrontal cortex and parietal cortex |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 65 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01567982 | ||||
| Other Study ID Numbers ICMJE | 1008007212, K01DA027750 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jiansong Xu, Yale University | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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