Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior

Study Overview
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Brief Summary
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This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

Detailed Description
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The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.

Official Title
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Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior

Conditions
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Tobacco Use

Intervention / Treatment
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* Other: Cigarette Brand Switching
* Other: E-cigarette Flavor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 or older Able to read English Cigarette smoker Exclusion Criteria: Seeking smoking cessation treatment Serious psychiatric or medical condition Use of other drugs Unable or unwilling to complete study protocol

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menthol e-cigarette<br>Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette | Other: Cigarette Brand Switching<br>* Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes<br>|
| Experimental: Tobacco e-cigarette<br>Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette | Other: E-cigarette Flavor<br>* Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Cigarettes Smoked | Self-reported total number of cigarettes smoked per day (Timeline Follow Back) | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E-cigarette Use | Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back) | Week 6 | 
| Tobacco Product Satisfaction | Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction | Week 6 | 
| Motivation to Quit Smoking | Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit | Week 6 | 
| Nicotine Dependence | Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence | Week 6 |