NCT05320887

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	Normal Nicotine Content Vape with all flavor e-liquids	Participants are randomly assigned to the order of each marketplace Group
OTHER	Normal nicotine content vape with tobacco e-liquids	Participants are randomly assigned to the order of each marketplace Group
OTHER	Low nicotine content vape with all flavor e-liquids	Participants are randomly assigned to the order of each marketplace Group
OTHER	Low nicotine content vape with tobacco e-liquids	Participants are randomly assigned to the order of each marketplace Group

Timeline

• Start date: 2022-07-27
• Primary completion: 2023-07-31
• Completion: 2023-08-06
• First posted: 2022-04-11
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

1 site across 1 country: United States