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

Not Applicable

Completed

Conditions: Tobacco Use

Interventions: Other: Low nicotine content vape with tobacco e-liquids
Other: Low nicotine content vape with all flavor e-liquids
Other: Normal Nicotine Content Vape with all flavor e-liquids
Other: Normal nicotine content vape with tobacco e-liquids

Registration Number: NCT05320887

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Low nicotine content vape with tobacco e-liquids	Low nicotine content vape with tobacco e-liquids	Low nicotine content vape with tobacco e-liquids
Low nicotine content vape with all flavor e-liquids	Low nicotine content vape with all flavor e-liquids	Low nicotine content vape with all flavor e-liquids
Normal Nicotine Content Vape with all flavor e-liquids	Normal Nicotine Content Vape with all flavor e-liquids	Normal Nicotine Content Vape with all flavor e-liquids
Normal nicotine content vape with tobacco e-liquids	Normal nicotine content vape with tobacco e-liquids	Normal nicotine content vape with tobacco e-liquids

Primary Outcome Measures

Name	Time	Method
Number of Cigarettes Purchased	Visit 6 approximately 4 weeks after baseline	Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)

Secondary Outcome Measures

Name	Time	Method
Number of E-liquid Milliliters Purchased	Visit 6 approximately 4 weeks after baseline	Average number of e-liquid milliliters purchased (analyzed as raw data and using derived behavioral economic measures)
Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections	Month 1 after baseline	The proportion of participants projected to choose a cigarette over an e-cigarette under different potential regulatory scenarios, as determined by regression analysis.
Lung Cancer Perceived Risk Scores for VLNC Cigarettes	Baseline	The response options rely on a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer.
Product Evaluation Scale Scores	Visit 6 approximately 4 weeks after baseline	Product evaluation scale scores for VLNC cigarettes among participants who received VLNC cigarettes will be determined by a product evaluation questionnaire. The questionnaire measures the strength of self-reported positive subjective effects (e.g., reward, satisfaction) following product use. 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. The summed score adds responses to 13 separate items. Minimum possible response: 13. Maximum possible response: 91. Higher scores denote more favorable product effects. Note: This was only administered (at Virtual Visit 6) to participants who received each product type in the field (dependent on their baseline ETM shopping trip purchases).
Minnesota Nicotine Withdrawal Scale Scores	Visit 6 approximately 4 weeks after baseline	Minnesota Nicotine Withdrawal Scale measures the severity 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. There are 7 items total, that are summed. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms.
Questionnaire on Smoking Urges Score	Visit 6 approximately 4 weeks after baseline	Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke.
Tobacco Product Interest Scores	1 month after baseline	Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested
Tobacco Policy Questionnaire Scores	1 month after baseline	Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on Making Cigarettes Less Addictive