Cigarette Smoking Decision Study

Study Overview
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Brief Summary
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The Family Smoking Prevention and Tobacco Control Act granted the FDA the authority to regulate and restrict tobacco advertising tactics that inaccurately convey reduced product risk, yet there is a dearth of up-to-date regulatory science to inform such regulations. Although the FDA has restricted use of descriptors such as natural and additive-free, research shows that the tobacco industry quickly pivoted to increase use of alternative, unregulated tactics. Greenwashing is one increasingly common tobacco marketing strategy in which products are portrayed as eco-friendly and/or natural. The investigators' preliminary research indicates that greenwashing tactics may inaccurately convey modified product risk to consumers. The overarching objective of this project is to test the effect of greenwashing methods used by cigarette companies to market products on actual smoking behavior in a controlled laboratory study. The investigators' proposed research focuses on young adults (age 18-29), because this is a key age for smoking initiation and escalation, and research has found that young adults may be more susceptible than older adults to greenwashing in cigarette ads. This study will test the effect of greenwashing on behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-administration study. These data will clearly connect tobacco advertising features to product risk perceptions and actual smoking behavior. This work will provide FDA with an integrated set of evidence that identifies misleading greenwashing tactics that inaccurately convey modified product risk which can be used to inform regulatory action regarding restrictions of this type of advertising.

Official Title
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Cigarette Smoking Decision Study

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: Smoking sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 29 years of age Smoke at least five cigarettes per day Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter Exclusion Criteria: The intention to quit smoking in the next 30 days Report roll your own cigarettes as an exclusive form of smoking A serious medical or psychiatric disorder or unstable condition Any positive toxicological screening for illicit drugs other than cannabis will be excluded Women who are pregnant, plan to become pregnant or are breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking sessions<br>This is the single arm that will go through cigarette smoking sessions | Behavioral: Smoking sessions<br>* Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demand intensity as assessed by a behavioral economic demand curve | Number of cigarettes smoked at no cost as measured by a demand curve | Through study completion, an average of 2 weeks | 
| Demand elasticity as assessed by a behavioral economic demand curve | Sensitivity of cigarette consumption to changes in cost for cigarettes | Through study completion, an average of 2 weeks | 
| Cross-price elasticity coefficients as assessed by a behavioral economic demand curve | Sensitivity of cigarette consumption to changes in cost for alternative products | Through study completion, an average of 2 weeks | 
| Change in total puff volume as measured by a smoking topography machine | Total cigarette puff volume in milliliters. | Days 2 and 3 |