Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

Study Overview
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Brief Summary
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The study will use functional magnetic resonance imaging and facial coding methods to study individuals who smoke cigarettes. Smoking expectancy (the extent to which one perceives an opportunity to smoke a cigarette) will be manipulated using instructions, and the investigators will examine the effects of this manipulation on two primary endpoints under conditions designed to induce an urge to smoke: (1) brain responses measured using fMRI and (2) subjective affective responses measured using facial coding. Secondary endpoints include self-report measures of the desire to smoke and current affect.

Official Title
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Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

Conditions
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Smoking, Tobacco

Intervention / Treatment
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* Behavioral: Verbal smoking expectancy manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be between the ages of 21 and 55. Participants must be right handed. Participants must be fluent English speakers. Participants must report smoking at least 6 cigarettes per day continuously for at least the 12 preceding months. Participants must have a baseline expired air carbon monoxide (CO) exceeding a cutoff based upon prior research in order to verify smoking status. Exclusion Criteria: Individuals will be excluded if they report that they are actively trying to quit smoking. Individuals will be excluded if they report that they have had significant cardiovascular disease (such as heart disease, heart attack, stroke, or angina) or respiratory disease (such as asthma, chronic bronchitis, or COPD) during the past year. Individuals will be excluded if they report that they have used any of the following illicit substances more than 10 times in the previous 30 days: marijuana, cocaine, opiates such as heroin, methadone, benzodiazepines (such as Valium, Xanax), barbiturates, amphetamines, methamphetamines, PCP, LSD or any other hallucinogen. Individuals will be excluded if they report that they are currently taking prescription medications that previously have been found to affect blood flow responses in the brain. Individuals will be excluded if they have any known risk from exposure to high-field strength magnetic fields (e.g., pace makers), any irremovable metallic foreign objects in their body (e.g., braces), or a questionable history of metallic fragments that are likely to create artifact on the MRI scans. Individuals will be excluded if they meet criteria for current dependence on a substance other than nicotine based upon a brief structured interview. Individuals will be excluded if they report that they are not willing to refrain from using alcohol and recreational drugs for 24 hours and nicotine for 12 hours before the experimental lab visit. Individuals will be excluded if they currently use nicotine products other than cigarettes (e.g., chewing tobacco, snuff, e-cigarettes, or smoking cessation products). Individuals will be excluded if they are claustrophobic or are prone to becoming very uncomfortable in confined spaces. Individuals will be excluded if they report that they exclusively or primarily smoke roll-your-own cigarettes.

Ages Eligible for Study
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Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Expect-Yes<br>Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. | Behavioral: Verbal smoking expectancy manipulation<br>* Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.<br>|
| Experimental: Experimental: Expect-No<br>Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. | Behavioral: Verbal smoking expectancy manipulation<br>* Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood-oxygen-level dependent (BOLD) signal | Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging will be compared between groups (participants assigned to the Expect-Yes and Expect-No experimental conditions). | Approximately Day 7 (Visit 2) | 
| Affect | Subjective affective responses will be measured by using the Facial Action Coding System to code the presence and intensity of facial movements reflecting emotional expression. | Approximately Day 7 (Visit 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desire to smoke | Self-report measures of the desire to smoke on a Visual Analog Scale ranging from 0 to 100, with higher scores indicating greater desire to smoke. | Approximately Day 7 (Visit 2) | 
| Reported affect | Self-report measures of current affect on a Visual Analog Scale ranging from 0 to 100, with higher scores indicating greater positive affect. | Approximately Day 7 (Visit 2) | 
| Nicotine dependence | Total score on the Fagerström Test for Nicotine Dependence, which measures level of nicotine dependence, will be evaluated as a moderator of primary endpoints. Scores on the Fagerström Test for Nicotine Dependence range from 0 to 10, with higher scores indicating greater nicotine dependence. | Day 1 (Visit 1) |