Neuroimaging Studies of Smoking and Treatment

Study Overview
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Brief Summary
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The purpose of this research study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment.

Official Title
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Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoke > 10 cigarettes per day vision is normal or corrected-to-normal Exclusion Criteria: serious medical illness unsuitable for the MR scanner based on best clinical judgment any neurologic or psychiatric disorder diabetes known heart disease high blood pressure currently taking psychotropic or cardiovascular medication history of alcohol or other substance dependence or current abuse risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc) pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT Treatment<br>Participants receive Cognitive behavioral therapy (CBT). Participants will receive 4 one hour CBT treatments. | Behavioral: Cognitive behavioral therapy<br>* Therapy focused on explaining the physiological and psychological effects of nicotine. Training is focused on adherence to smoking instructions, physiological and psychological effects of nicotine, reviewing reasons for quitting, and coping with smoking urges. Smokers will be asked to begin smoking on a set schedule leading up to their quit day.<br>* Other names: CBT;|
| Active Comparator: Control Group<br>Participants receive health education treatment. Participants will attend treatment sessions that match the CBT Treatment arm with respect to time and contact. | Behavioral: Health education<br>* Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.<br>|
| No Intervention: Control Group - Scans<br>Participants in this new arm to the study will receive no intervention and will receive three scans. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activation in reward processing regions of the brain |  | Change from Baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activation in cognitive control regions of the brain |  | Change from Baseline to Week 4 | 
| Change in connectivity between reward and cognitive control regions of the brain |  | Change from Baseline to Week 4 |