Neuroimaging Studies of Practice and Smoking

Study Overview
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Brief Summary
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The purpose of this research study is to help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.

Detailed Description
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The study is comprised of two parts: a pilot to test procedures to be used in the study, followed by the study. The pilot phase of this study will enroll 30 participants. The main study will enroll 80 after the pilot phase is completed. The pilot phase includes all of the same procedures as the main study.

Official Title
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Smoking Cessation and Brain Activation: How Practice Changes the Brain

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Delay time to first cigarette
* Behavioral: Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoke > 10 cigarettes per day for the last 6 months Smokes first cigarette within 60 minutes after waking Vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response) Willing to complete all appointments and change smoking behaviors for 2 weeks No quit attempts or attempts to cut back in the last 30 days No plans to quit in the next 30 days High school graduate or General Eduction Diploma (GED) Exclusion Criteria: Serious medical illness unsuitable for the magnetic resonance imaging (MRI) scanner based on best clinical judgment Any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder), or attention-deficit disorder/attention-deficit hyperactivity disorder Currently taking anti-seizure medication History of concussion Body mass index (BMI) over 50 Left-handedness 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: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practice<br>Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks. | Behavioral: Delay time to first cigarette<br>* Participants asked to delay time until they smoke first cigarette of the day.<br>Behavioral: Therapy<br>* Participants receive tips on how to resist the urge to smoke and control cravings to smoke.<br>|
| Active Comparator: No Practice<br>Participants will continue with their normal smoking behavior. | Behavioral: Therapy<br>* Participants receive tips on how to resist the urge to smoke and control cravings to smoke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues | Change measured via functional magnetic resonance imaging (fMRI) | Baseline (Day 7) to End of Study (Day 22) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues | Change measured via functional magnetic resonance imaging (fMRI) | Baseline (Day 7) to End of Study (Day 22) |