Nicotine Withdrawal Clinical Trial
Official title:
Phase 1 Study of Effects of tDCS on Tobacco Withdrawal Symptoms
We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.
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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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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