Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors

Study Overview
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Brief Summary
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In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.

Official Title
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Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Device: active tDCS
* Device: sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between the ages of 18 and 64 Smoked (on average) at least 5 cigarettes per day Be motivated to quit smoking Exclusion Criteria: Unstable medical or psychiatric conditions Any medical conditions with neurological sequelae History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications). Are pregnant or planning to become pregnant during the study Current use of pacemaker, intracranial electrodes or implanted defibrillator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active tDCS<br>Participants receive active tDCS for five consecutive days before attempting to quit smoking | Device: active tDCS<br>* two 13 minute tDCS sessions separated by 20 minutes in between<br>|
| Sham Comparator: sham tDCS<br>Participants receive sham tDCS for five consecutive days before attempting to quit smoking | Device: sham tDCS<br>* sham tDCS session given for same length of time as active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Willing to Complete 5 Days of tDCS or Sham | As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Cigarettes Smoked Per Day | Change in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period. | 4 weeks |