Clinical trial NCT05320887: Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)
Official title: The Impact of Cigarette Nicotine Content, E-Cigarette Nicotine Content and E-Cigarette Flavoring on Smoking Behavior in an Electronic Tobacco Marketplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: Cigarette smoking
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2022-04-11
Enrollment: 69
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants are randomly assigned to either low nicotine or normal nicotine content vaping devices with tobacco flavors only available
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Cigarettes Purchased
timeFrame: Visit 6 approximately 4 weeks after baseline
Secondary outcomes:
measure: Number of E-liquid Milliliters Purchased
timeFrame: Visit 6 approximately 4 weeks after baseline
measure: Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections
timeFrame: Month 1 after baseline
measure: Lung Cancer Perceived Risk Scores for VLNC Cigarettes
timeFrame: Baseline
measure: Product Evaluation Scale Scores
timeFrame: Visit 6 approximately 4 weeks after baseline
measure: Minnesota Nicotine Withdrawal Scale Scores
timeFrame: Visit 6 approximately 4 weeks after baseline
measure: Questionnaire on Smoking Urges Score
timeFrame: Visit 6 approximately 4 weeks after baseline
measure: Tobacco Product Interest Scores
timeFrame: 1 month after baseline
measure: Tobacco Policy Questionnaire Scores
timeFrame: 1 month after baseline
Other outcomes:
measure: Product Use Themes Emerging From the Qualitative Interviews
timeFrame: Screening visit through end of study (up to week eight)
measure: Tobacco Product Use During Field Assessment
timeFrame: Screening visit through end of study (up to week eight)
measure: Biomarkers of Exposure During Field Assessment - Carbon Monoxide
timeFrame: Screening visit through end of study (up to week eight)
measure: Biomarkers of Exposure During Field Assessment - Cotinine
timeFrame: Screening visit through end of study (up to week eight)
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Eric M Donny, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jarvis MJ, Bates C. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106-7; author reply 107-9. No abstract available.
citation: Kozlowski LT. Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. Int J Drug Policy. 2015 Jun;26(6):543-7. doi: 10.1016/j.drugpo.2015.02.001. Epub 2015 Feb 23.
citation: Kozlowski LT. Cigarette prohibition and the need for more prior testing of the WHO TobReg's global nicotine-reduction strategy. Tob Control. 2017 Mar;26(e1):e31-e34. doi: 10.1136/tobaccocontrol-2016-052995. Epub 2016 Jun 29. No abstract available.
citation: Kozlowski LT. Let actual markets help assess the worth of optional very-low-nicotine cigarettes before deciding on mandatory regulations. Addiction. 2017 Jan;112(1):3-5. doi: 10.1111/add.13515. Epub 2016 Aug 23. No abstract available.
citation: Shatenstein S. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106; author reply 107-9. No abstract available.
citation: Henningfield JE, Benowitz NL, Slade J, Houston TP, Davis RM, Deitchman SD. Reducing the addictiveness of cigarettes. Council on Scientific Affairs, American Medical Association. Tob Control. 1998 Autumn;7(3):281-93. doi: 10.1136/tc.7.3.281.
citation: Hatsukami DK, Perkins KA, Lesage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M. Nicotine reduction revisited: science and future directions. Tob Control. 2010 Oct;19(5):e1-10. doi: 10.1136/tc.2009.035584.
citation: World Health Organization. WHO STUDY GROUP ON TOBACCO PRODUCT REGULATION. Report on the Scientific Basis of Tobacco Product Regulations: Fifth Report of a WHO Study Group. World Health Organ Tech Rep Ser. 2015;(989):1-234, back cover.