Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors

Smoking Clinical Trial

Official title:

Project 2: The Impact of Cigarette Nicotine Content, E-cigarette Nicotine Content, and E-cigarette Flavoring on Smoking Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185546
• Other study ID #: IRB00047676
• Secondary ID: 1U54DA031659-01U
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: April 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Smokers who have tried vaping multiple times.
• Generally good health.

Exclusion Criteria:

• If female, currently pregnant, trying to become pregnant or breastfeeding.
• Planning to quit smoking.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• NNC Spectrum Cigarette
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
• VLNC Spectrum Cigarette
Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
• Moderate nicotine level e-liquid
Participants are provided with moderate nicotine level e-liquid for 13 weeks
• Low nicotine level e-liquid
Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
• Tobacco Flavors
Participants can choose e-liquid flavors from a selection of tobacco flavors
• Tobacco and non-tobacco e-liquid flavors
Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Wake Forest Biotech Place	Winston-Salem	North Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Bandiera FC, Ross KC, Taghavi S, Delucchi K, Tyndale RF, Benowitz NL. Nicotine Dependence, Nicotine Metabolism, and the Extent of Compensation in Response to Reduced Nicotine Content Cigarettes. Nicotine Tob Res. 2015 Sep;17(9):1167-72. doi: 10.1093/ntr/ntu337. Epub 2015 Jan 2. — View Citation

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Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Progressive commercial cigarette yield reduction: biochemical exposure and behavioral assessment. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):876-83. doi: 10.1158/1055-9965.EPI-08-0731. Epub 2009 Mar 3. — View Citation

Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21. — View Citation

Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol Biomarkers Prev. 2007 Nov;16(11):2479-85. — View Citation

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Benowitz NL, Nardone N, Dains KM, Hall SM, Stewart S, Dempsey D, Jacob P 3rd. Effect of reducing the nicotine content of cigarettes on cigarette smoking behavior and tobacco smoke toxicant exposure: 2-year follow up. Addiction. 2015 Oct;110(10):1667-75. doi: 10.1111/add.12978. Epub 2015 Jul 21. — View Citation

Benowitz NL, Pomerleau OF, Pomerleau CS, Jacob P 3rd. Nicotine metabolite ratio as a predictor of cigarette consumption. Nicotine Tob Res. 2003 Oct;5(5):621-4. — View Citation

Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. — View Citation

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Caggiula AR, Donny EC, White AR, Chaudhri N, Booth S, Gharib MA, Hoffman A, Perkins KA, Sved AF. Cue dependency of nicotine self-administration and smoking. Pharmacol Biochem Behav. 2001 Dec;70(4):515-30. Review. — View Citation

Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2000. MMWR Morb Mortal Wkly Rep. 2002 Jul 26;51(29):642-5. — View Citation

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Conklin CA, Tiffany ST. Applying extinction research and theory to cue-exposure addiction treatments. Addiction. 2002 Feb;97(2):155-67. — View Citation

Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. — View Citation

Dawkins L, Turner J, Crowe E. Nicotine derived from the electronic cigarette improves time-based prospective memory in abstinent smokers. Psychopharmacology (Berl). 2013 Jun;227(3):377-84. doi: 10.1007/s00213-013-2983-2. Epub 2013 Jan 24. — View Citation

Dawkins L, Turner J, Hasna S, Soar K. The electronic-cigarette: effects on desire to smoke, withdrawal symptoms and cognition. Addict Behav. 2012 Aug;37(8):970-3. doi: 10.1016/j.addbeh.2012.03.004. Epub 2012 Mar 10. — View Citation

Dempsey D, Tutka P, Jacob P 3rd, Allen F, Schoedel K, Tyndale RF, Benowitz NL. Nicotine metabolite ratio as an index of cytochrome P450 2A6 metabolic activity. Clin Pharmacol Ther. 2004 Jul;76(1):64-72. — View Citation

Food and Drug Administration, HHS. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Final rule. Fed Regist. 2016 May 10;81(90):28973-9106. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Minnesota Nicotine Withdrawal Scale	Measure of discomfort and dysfunction; 15-item self-reported scale to evaluate the effects of smoking cessation. Score ranges from 0 to 60 with higher score denoting more severe symptoms.	Baseline-Week 12
Other	Number of Days Using Assigned Vaping Device	collected through Interactive Voice Response (IVR) Review	Baseline-Week 12
Other	Cigarette Evaluation Scale	Assesses the extent to which the product they just sampled produced various subjective effects including satisfaction, good taste, dizziness, reduced appetite, nausea, and enjoyable sensations in the throat and chest. Score ranges from 1 to 91 with a higher score denoting more positive sensations.	Baseline-Week 12
Other	Mercapturic Acids	Measure of toxicant exposure	Baseline-Week 12
Other	Fagerstrom Nicotine Dependence Scale	Dependence Measure	Baseline-Week 12
Other	Study Cigarettes Smoked Per Day	Study cigarettes smoked per day	Baseline-Week 12
Other	IVR Review and Timeline Followback and E-liquid Accountability	Measure of vaping device use	Baseline-Week 12
Other	Number of Choices to Smoke in Preference Assessment Task	Measure of relative reinforcement	Week 00
Other	Purchase Task	Measure of relative reinforcement and substitution	Baseline, Week 12
Other	Predicted Behavior Questionnaire	Measure of hypothetical cigarette and vaping device use	Week 12
Other	IVR Review and Timeline Followback	Measure of compliance	Baseline-Week 12
Other	Drop-out Rate	Drop-out rate	Baseline-Week 12
Other	Urge to Use Questionnaire	Measure of discomfort and dysfunction	Baseline-Week 12
Other	Center for Epidemiologic Studies Depression Scale	Measure of discomfort and dysfunction	Baseline, Weeks 04, 08, 12
Other	Breath Alcohol	Alcohol use	Baseline - Week 12
Other	Urine Drug Screen	Drug use	Baseline, Week 12
Other	Alcohol Use Questionnaire	Alcohol use	Baseline-Week 12
Other	Drug Use Questionnaire	Drug use	Baseline-Week 12
Other	Weight	Weight	Baseline-Week 12
Other	Urinary Anatabine Biomarker	Measure of cigarette exposure and compliance	Baseline -Week 12
Other	Total Nicotine Equivalents	Measure of nicotine exposure	Baseline - Week 12
Other	Environmental and Social Influences on Tobacco Use Questionnaire	Measure of smoking and vaping context	Baseline-Week 12
Other	Context of Product Use Questionnaire	Measure of smoking and vaping context	Baseline-Week 12
Other	Puff Topography	Measure of smoking and vaping topography	Weeks 01 and 10
Other	Vaping Utility Questionnaire	Measure of product expectancy	Baseline, Week 12
Other	Smoking and Vaping Expectancy Questionnaires	Measure of product expectancy	Baseline-Week 12
Other	Cigarette and Product Evaluation Scale	Measure of product characteristics	Baseline-Week 12
Other	Perceived Health Risk Questionnaire	Measure of perceived personal health risk	Baseline-Week 12
Other	Penn State Smoking Dependence Questionnaire	Dependence Measure (smoking and vaping)	Baseline-Week 12
Other	Primary Subscales From Brief Wisconsin Inventory of Smoking Dependence Motive (WISDM)	Dependence Measure	Baseline-Week 12
Other	Population Assessment of Tobacco and Health (PATH) Smoking Dependence Questions	Dependence Measure (smoking and vaping)	Baseline-Week 12
Other	Stages of Change	Measure of intention to quit	Baseline-Week 12
Other	Contemplation Ladder	Measure of intention to quit	Baseline-Week 12
Other	Quit Attempts	Measure of intention to quit	Baseline-Week 12
Other	Post-intervention Changes in Tobacco Use Behavior	Measure of 30-day tobacco use post-intervention of study products	30 Day Follow up
Other	Qualitative Interview	Themes related to product use patterns, e-liquid flavor selection, non-compliance and general study feedback	30 Day Follow up
Primary	Total Cigarettes Smoked Per Day	The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).	Week 10 through Week 12
Secondary	Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)	Measure of cigarette smoke exposure using data on expired breath CO. CO was captured using Covita Smokelyzer devices and standard exhalation procedures. The unit of measurement is parts per million (ppm).	Baseline - Week 12
Secondary	Number of Subjects With Smoke Free Days	Study team generates the smoke free days outcome by counting days where no cigarettes and no other forms of combusted tobacco products are used. Days where participants use no nicotine products and days where participants only vape are "smoke free." Percentage of smoke free days = the number days that participants reported smoking 0 cigarettes (0 study cigarettes and 0 non-study cigarettes) divided by the total number of days between their randomization and Week 12 visits. Due to the distribution of the data, statisticians grouped participants according to whether they had 0 smoke-free days or more than 0 smoke free days during the study.	Baseline-Week 12