Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)
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Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
69 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Darcy L Laverdiere, BA; Eric C Donny, PhD
Data sourced from clinicaltrials.gov
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