Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)

Study Overview
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Brief Summary
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This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.

Detailed Description
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The Family Smoking Prevention and Tobacco Control Act (FSPTCA) passed in 2009 provides the FDA with the authority to regulate tobacco products. One provision in this legislative act empowers the FDA to set limits on constituents in tobacco products, including nicotine. Such a measure has the potential to reduce the chance of individuals experimenting with smoking from becoming dependent and enable current smokers to quit when they are motivated to do so. Although the proposal to reduce nicotine in cigarettes has been met with skepticism by some because of concerns over compensatory smoking behavior and the potential emergence of a black market, this policy measure was considered to be technically feasible by the American Medical Association and the British Medical, by tobacco control researchers, policymakers and governmental officials who were convened in a meeting on nicotine regulation8, and by the World Health Organization Study Group on Tobacco Product Regulation. Most importantly, in July 2017, FDA Commissioner Gottlieb announced he was directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction. This announcement was followed on March 16, 2018 by the release of the Advance Notice of Proposed Rulemaking entitled Tobacco Product Standard for Nicotine Level of Combusted Cigarettes (ID: FDA-2017-N-6189-0001) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. This study proposes to conduct a within-subjects, multi-session virtual lab study and validation field assessment to determine how the availability of flavored e-liquids affects product purchasing among cigarette smokers. Adult daily cigarette smokers (N=64) will be recruited for this study. After initial eligibility is assessed, participants will complete six virtual sessions (1 baseline, 4 experimental, and 1 follow-up) and one field assessment to evaluate their tobacco use.

Official Title
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The Impact of Cigarette Nicotine Content, E-Cigarette Nicotine Content and E-Cigarette Flavoring on Smoking Behavior in an Electronic Tobacco Marketplace

Conditions
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Tobacco Use

Intervention / Treatment
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* Other: Normal Nicotine Content Vape with all flavor e-liquids
* Other: Normal nicotine content vape with tobacco e-liquids
* Other: Low nicotine content vape with all flavor e-liquids
* Other: Low nicotine content vape with tobacco e-liquids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21+ years of age Self-report smoking at least 5 cigarettes per day for the past year Breathe carbon monoxide (CO) level > 8 ppm or positive urine NicCheck Willingness to use other tobacco products during the study Speak, comprehend, and read English sufficiently to complete study procedures Have home access to a computer, smart phone, or tablet with a web camera and internet access Tried a vaping device at least once in their lifetime Exclusion Criteria: Currently seeking treatment to quit smoking Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases Body temperature > 100.4 F Cold, flu or COVID-19 symptoms including fever, cough, and runny nose in the past 30 days Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy CO reading > 80 ppm

Ages Eligible for Study
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Minimum Age: 21 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: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Participants are randomly assigned to either low nicotine or normal nicotine content vaping devices with tobacco flavors only available
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Nicotine Content Vape with all flavor e-liquids<br>Normal Nicotine Content Vape with all flavor e-liquids | Other: Normal Nicotine Content Vape with all flavor e-liquids<br>* Participants are randomly assigned to the order of each marketplace Group<br>|
| Experimental: Normal nicotine content vape with tobacco e-liquids<br>Normal nicotine content vape with tobacco e-liquids | Other: Normal nicotine content vape with tobacco e-liquids<br>* Participants are randomly assigned to the order of each marketplace Group<br>|
| Experimental: Low nicotine content vape with all flavor e-liquids<br>Low nicotine content vape with all flavor e-liquids | Other: Low nicotine content vape with all flavor e-liquids<br>* Participants are randomly assigned to the order of each marketplace Group<br>|
| Experimental: Low nicotine content vape with tobacco e-liquids<br>Low nicotine content vape with tobacco e-liquids | Other: Low nicotine content vape with tobacco e-liquids<br>* Participants are randomly assigned to the order of each marketplace Group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cigarettes purchased | Number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of E-liquid purchased | E-liquid purchased (analyzed as raw data and using derived behavioral economic measures) | 1 year | 
| Proportion of Participants completing Flavor and Nicotine Content Discrete Choice Projections | The proportion of participants projected to choose a cigarette over an e-cigarette under different potential regulatory scenarios, as determined by logistic regression | 1 year | 
| Perceived Health Risk Scale Scores | Perceived Health Risk Scale - The response options rely on a 5-point Likert-like scale: 0=no risk; 1=low risk; 2=moderate risk; 3=high risk; 4=very high risk | 1 year | 
| Product Evaluation Scale Scores | Product Evaluation Scale - which measures responses to cigarettes (e.g., reward, satisfaction) - The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely | 1 year | 
| Minnesota Nicotine Withdrawal Scale Scores | Minnesota Nicotine Withdrawal Scale - a measure of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe | 1 year | 
| Questionnaire on Smoking Urges Score | Questionnaire on Smoking Urges - measures the urge to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree | 1 year | 
| Tobacco Product Interest Scores | Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested | 1 year | 
| Tobacco Policy Questionnaire Scores | Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on relevant Tobacco Policies | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette smoking