Experimental Tobacco Marketplace in Regulating Flavored Tobacco Products in Menthol Cigarette Smokers

Study Overview
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Brief Summary
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This trial uses an Experimental Tobacco Marketplace to study the purchase of tobacco products in menthol cigarette smokers. Determining the level of substitutability of both flavored and unflavored/tobacco flavored e-cigarettes when menthol cigarettes are available and unavailable can help determine if a flavor ban (of either menthol cigarettes and/or flavored e-cigarettes) will lead to smoking cessation and/or harm reduction. A greater understanding of tobacco product purchasing could help inform possible regulatory actions by the Food and Drug Administration.

Detailed Description
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Participants view and purchase hypothetical tobacco products during four distinctly different Experimental Tobacco Marketplace (ETM) conditions. During the session, participants are presented with these randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.

Official Title
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Flavored Tobacco Product Regulation: Behavioral Economic Demand, Visual Attention, and Flavored Tobacco Product Availability

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: Smoking Cessation Intervention
* Other: Functional Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Menthol cigarette smokers who report smoking a brand that has a non-menthol equivalent. Residing in Western New York. Voluntarily provide informed consent to participate in the study. Exclusion Criteria: Any known history of macular degeneration, glaucoma, cataracts, eye implant, permanently dilated pupils or the use of a screen reader/magnifier. The following special populations will not be included: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Prisoners Pregnant women

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention<br>During the session, participants are presented with randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment. | Behavioral: Smoking Cessation Intervention<br>* View and purchase hypothetical tobacco products during four distinctly different ETM<br>Other: Functional Assessment<br>* Visual attention is evaluated via eye-tracking equipment<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of Menthol flavored cigarettes | Number of flavored cigarettes purchased inThe Experimental Market Place (ETM) will be used to track tobacco purchase behaviors | At the time of the session , assessed up to 15 months | 
| Eye tracking metrics | the interaction of type of cigarette available (menthol versus non-menthol) and type of e-cigarette available (flavors versus unflavored and tobacco), will employ a 2 X 2 repeated measures ANOVA with post-hoc Bonferroni tests to evaluate the outcomes of Q0 (derived initial consumption without cost constraints), α (demand elasticity), the substitution levels, and the eye-tracking metrics. | At the time of the session , assessed up to 15 months |