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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320887
• Other study ID #: IRB00080010
• Secondary ID: 5U54DA031659-09
• Status: Completed
• Phase: N/A
• Start date: July 27, 2022
• Est. completion date: August 6, 2023

Study information

• Verified date: March 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 6, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Normal Nicotine Content Vape with all flavor e-liquids
Participants are randomly assigned to the order of each marketplace Group
• Normal nicotine content vape with tobacco e-liquids
Participants are randomly assigned to the order of each marketplace Group
• Low nicotine content vape with all flavor e-liquids
Participants are randomly assigned to the order of each marketplace Group
• Low nicotine content vape with tobacco e-liquids
Participants are randomly assigned to the order of each marketplace Group

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View Citation

Jarvis MJ, Bates C. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106-7; author reply 107-9. No abstract available. — View 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. — View 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. — View 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. — View Citation

Shatenstein S. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106; author reply 107-9. No abstract available. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Product use themes emerging from the qualitative interviews	Participants are asked about their opinions and experiences using tobacco products other than their usual brand during the field assessment.	1 year
Other	Tobacco Product use during Field Assessment	Participants are asked what products they had used and quantity every day during the field assessment.	1 year
Other	Biomarkers of exposure during Field Assessment - Carbon Monoxide	Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Carbon Monoxide (CO) is collected in ppm.	1 year
Other	Biomarkers of exposure during Field Assessment - Cotinine	Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Cotinine is collected in ng/ml.	1 year
Primary	Number of cigarettes purchased	Number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)	1 year
Secondary	Amount of E-liquid purchased	E-liquid purchased (analyzed as raw data and using derived behavioral economic measures)	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tobacco Product Interest Scores	Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested	1 year
Secondary	Tobacco Policy Questionnaire Scores	Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on relevant Tobacco Policies	1 year