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Grant Details

Grant Number: 5R01CA204891-05 Interpret this number
Primary Investigator: Wagener, Theodore
Organization: Ohio State University
Project Title: Examination of First and Second Generation E-Cigarettes
Fiscal Year: 2020


Abstract

 DESCRIPTION (provided by applicant): The 2009 Family Smoking Prevention and Tobacco Control Act grants the FDA regulatory authority over tobacco-based products. However, the FDA only recently proposed deeming regulations on e-cigarettes. Since their market emergence, e-cigarettes have evolved from first generation products, which look like a conventional cigarette, have few design components and limited nicotine delivery, to second generation products, which do not look like conventional cigarettes, have multiple design components and can achieve cigarette-like levels of nicotine-delivery. Missing from the current literature is a prospective study assessing differences between these two major types of e-cigarettes on smoking behaviors and patterns, nicotine dependence, and on biomarkers of toxicant exposure and effect. Understanding the differential impact of first versus second generation e-cigarettes on smoking as well as measures of proximal health outcomes will help immediately inform the science base needed for the FDA to impose appropriate product specific regulations. The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a first or second generation e-cigarette on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects. To do so, we will randomly assign 453 adult smokers, naïve to e-cigarette use, to first generation e-cigarette (G1), second generation e-cigarette (G2), or usual brand cigarette control (UBC). All products will be provided for 12 weeks. Enrollment will be restricted only to smokers not planning to quit in the next 3 months. Prior to randomization, all participants will take part n a lead-in period to assess normal smoking behavior and to allow for stratification on important variables. Follow- ups will occur at 1, 4, 8, 12, 26, and 52 weeks. Our specific aims are to 1) assess the effect of provision of G1 vs. G2 on product switching, abuse liability, number of cigarettes smoked, and perceived nicotine dependence; 2) evaluate changes in biomarkers of harmful tobacco constituent exposure among participants assigned to G1, G2, and UBC; and 3) evaluate changes in biomarkers of toxicant effect among participants assigned to G1, G2, and UBC. This innovative study in its comprehensive examination of all e-cigarette devices as well as their impact on smoking behavior and health outcomes, will provide the scientific foundation the FDA and other agencies need to establish effective regulatory strategies for the manufacture, distribution, and marketing of e- cigarettes.



Publications

Youth use of e-cigarettes: Does dependence vary by device type?
Authors: Tackett A.P. , Hébert E.T. , Smith C.E. , Wallace S.W. , Barrington-Trimis J.L. , Norris J.E. , Lechner W.V. , Stevens E.M. , Wagener T.L. .
Source: Addictive behaviors, 2021 08; 119, p. 106918.
EPub date: 2021-03-23.
PMID: 33798918
Related Citations

Associated Changes in E-cigarette Puff Duration and Cigarettes Smoked per Day.
Authors: Wagener T.L. , Avery J.A. , Leavens E.L.S. , Simmons W.K. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021-03-19; 23(4), p. 760-764.
PMID: 33049064
Related Citations

Vape Shop Owners/Managers' Opinions About FDA Regulation of E-Cigarettes.
Authors: Berg C.J. , Barker D.C. , Sussman S. , Getachew B. , Pulvers K. , Wagener T.L. , Hayes R.B. , Henriksen L. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021-02-16; 23(3), p. 535-542.
PMID: 32722808
Related Citations

Exploring the Point-of-Sale Among Vape Shops Across the United States: Audits Integrating a Mystery Shopper Approach.
Authors: Berg C.J. , Barker D.C. , Meyers C. , Weber A. , Park A.J. , Patterson A. , Dorvil S. , Fairman R.T. , Huang J. , Sussman S. , et al. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2021-02-16; 23(3), p. 495-504.
PMID: 32149340
Related Citations

Vape shop owners'/managers' attitudes about CBD, THC, and marijuana legal markets.
Authors: Berg C.J. , Getachew B. , Pulvers K. , Sussman S. , Wagener T.L. , Meyers C. , Park A. , Dorvil S. , Patterson A. , Weber A. , et al. .
Source: Preventive medicine reports, 2020 Dec; 20, p. 101208.
EPub date: 2020-09-12.
PMID: 32995147
Related Citations

E-cigarette regulation: a delicate balance for public health.
Authors: Tackett A.P. , Hébert E.T. , Stevens E.M. , Wagener T.L. .
Source: Addiction (Abingdon, England), 2020 12; 115(12), p. 2197-2199.
EPub date: 2020-05-08.
PMID: 32307739
Related Citations

Vape shop and consumer activity during COVID-19 non-essential business closures in the USA.
Authors: Berg C.J. , Callanan R. , Johnson T.O. , Schliecher N.C. , Sussman S. , Wagener T.L. , Meaney M. , Henriksen L. .
Source: Tobacco control, 2020-10-19; , .
EPub date: 2020-10-19.
PMID: 33077506
Related Citations

Electronic cigarette use and sleep health in young adults.
Authors: Brett E.I. , Miller M.B. , Leavens E.L.S. , Lopez S.V. , Wagener T.L. , Leffingwell T.R. .
Source: Journal of sleep research, 2020 06; 29(3), p. e12902.
EPub date: 2019-09-04.
PMID: 31486154
Related Citations

Electronic cigarette and combustible cigarette use following a campus-wide ban: Prevalence of use and harm perceptions.
Authors: Leavens E.L.S. , Lechner W.V. , Stevens E.M. , Miller M.B. , Meier E. , Brett E.I. , Moisiuc A. , Hale J.J. , Wagener T.L. .
Source: Journal of American college health : J of ACH, 2020 May-Jun; 68(4), p. 332-335.
EPub date: 2019-01-25.
PMID: 30681933
Related Citations

JUUL in school: JUUL electronic cigarette use patterns, reasons for use, and social normative perceptions among college student ever users.
Authors: Leavens E.L.S. , Stevens E.M. , Brett E.I. , Leffingwell T.R. , Wagener T.L. .
Source: Addictive behaviors, 2019 12; 99, p. 106047.
EPub date: 2019-07-09.
PMID: 31442788
Related Citations

Perceptions of Smoking and Vaping on Weight Control Among Adult American Indians Who Smoke.
Authors: Rhoades D.A. , Comiford A.L. , Dvorak J.D. , Ding K. , Hopkins M. , Spicer P. , Wagener T.L. , Doescher M.P. .
Source: Journal of community health, 2019 12; 44(6), p. 1120-1126.
PMID: 31273619
Related Citations

JUUL electronic cigarette use patterns, other tobacco product use, and reasons for use among ever users: Results from a convenience sample.
Authors: Leavens E.L.S. , Stevens E.M. , Brett E.I. , Hébert E.T. , Villanti A.C. , Pearson J.L. , Wagener T.L. .
Source: Addictive behaviors, 2019 08; 95, p. 178-183.
EPub date: 2019-02-18.
PMID: 30933713
Related Citations

The relationship between nicotine metabolism and nicotine and carcinogen exposure among American Indian commercial cigarette smokers and electronic nicotine delivery system users.
Authors: Carroll D.M. , Wagener T.L. , Stephens L.D. , Brame L.S. , Thompson D.M. , Beebe L.A. .
Source: Addictive behaviors, 2019 05; 92, p. 58-63.
EPub date: 2018-10-28.
PMID: 30583092
Related Citations

Polytobacco use and risk perceptions among young adults: The potential role of habituation to risk.
Authors: Leavens E.L.S. , Meier E. , Brett E.I. , Stevens E.M. , Tackett A.P. , Villanti A.C. , Wagener T.L. .
Source: Addictive behaviors, 2019 03; 90, p. 278-284.
EPub date: 2018-11-08.
PMID: 30472536
Related Citations

Will the Debate Over e-Cigarettes Start Cooling Down?
Authors: Wagener T.L. .
Source: JAMA network open, 2018-12-07; 1(8), p. e185945.
EPub date: 2018-12-07.
PMID: 30646289
Related Citations

Social and substance use correlates of adult hookah use, 2016.
Authors: Abudayyeh H.S. , Glasser A.M. , Johnson A.L. , Cohn A.M. , Wagener T.L. , Mays D. , Villanti A.C. .
Source: Addictive behaviors, 2018 04; 79, p. 39-44.
EPub date: 2017-12-09.
PMID: 29245025
Related Citations

Have combustible cigarettes met their match? The nicotine delivery profiles and harmful constituent exposures of second-generation and third-generation electronic cigarette users.
Authors: Wagener T.L. , Floyd E.L. , Stepanov I. , Driskill L.M. , Frank S.G. , Meier E. , Leavens E.L. , Tackett A.P. , Molina N. , Queimado L. .
Source: Tobacco control, 2017 03; 26(e1), p. e23-e28.
EPub date: 2016-10-11.
PMID: 27729564
Related Citations

A Proposed Collaboration Against Big Tobacco: Common Ground Between the Vaping and Public Health Community in the United States.
Authors: Wagener T.L. , Meier E. , Tackett A.P. , Matheny J.D. , Pechacek T.F. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2016 May; 18(5), p. 730-6.
EPub date: 2015-10-26.
PMID: 26508399
Related Citations

The comparative efficacy of first- versus second-generation electronic cigarettes in reducing symptoms of nicotine withdrawal.
Authors: Lechner W.V. , Meier E. , Wiener J.L. , Grant D.M. , Gilmore J. , Judah M.R. , Mills A.C. , Wagener T.L. .
Source: Addiction (Abingdon, England), 2015 May; 110(5), p. 862-7.
EPub date: 2015-03-05.
PMID: 25639148
Related Citations




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