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Grant Details

Grant Number: 5P01CA217806-05 Interpret this number
Primary Investigator: Hatsukami, Dorothy
Organization: University Of Minnesota
Project Title: Consortium on Methods Evaluating Tobacco (COMET): Filterventilation and Product Standards
Fiscal Year: 2021


Abstract

ABSTRACT The 2014 Surgeon General Report (SGR) concluded that there has been an unanticipated increase in lung adenocarcinomas, now the most common type of lung cancer. The SGR identified ventilation in cigarette filters, a design introduced in the 1960s and an important way to lower machine measured cigarette tar yields, as a potential contributor to the increase in these lung cancers. In a recent review, we found highly suggestive evidence that filter ventilated cigarettes was the cause of the increased incidence of adenocarcinoma lung cancer and concluded that there was enough evidence for the FDA to consider regulating filter ventilation, including a ban. Independent of the risk for adenocarcinoma, there would be sufficient justification for regulation based on the impact of ventilation on harmful constituent yields, smoking behavior and smokers' misperception of health risks. However, prior to any regulatory action, the consequences of such a ban needs to be studied. This P01 describes a set of systematic and comprehensive studies that examines the toxicity, appeal and abuse liability of unventilated filters as compared to ventilated filters in the context of a marketplace with and without alternative nicotine delivery systems (ANDS). Four integrated projects and three cores are proposed and involve a team of multi-disciplinary investigators who have worked together in developing validated models and measures to test tobacco products. The four projects address 1) how unventilated vs. ventilated cigarettes are smoked and the resulting carcinogen exposure levels and potential harm when used with and without ANDS (Project 1); 2) the relative abuse liability of these ventilated vs. unventilated cigarettes and the extent to which ANDS serves as a substitute for unventilated cigarettes (Projects 2 and 3); and 3) the effects of ventilation and product packaging/messaging on consumer perceptions of harm, response and uptake and how these perceptions can be modified by ANDS (Project 4). This research is novel in many ways, including the first to assess the impact of removing filter ventilation and doing this in the context of a complex tobacco marketplace. The projects that we propose are highly integrated. None of these studies alone can address the population impact of a ban on ventilation. It is the combination of these complementary studies that can address the impact of a ban on toxicity, uptake and intensity of product use to determine population health impact. The results of this study would provide critical information to the U.S. Food and Drug Administration on whether or not a ban would lead to improved public health.



Publications

Cigarette Filter Ventilation and Biomarkers-Reply.
Authors: Carroll D.M. , Hatsukami D.K. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2021 Jul; 30(7), p. 1450.
PMID: 34210677
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Ethnic Differences of Urinary Cadmium in Cigarette Smokers from the Multiethnic Cohort Study.
Authors: Cigan S.S. , Murphy S.E. , Alexander B.H. , Stram D.O. , Hatsukami D.K. , Le Marchand L. , Park S.L. , Stepanov I. .
Source: International journal of environmental research and public health, 2021-03-06; 18(5), .
EPub date: 2021-03-06.
PMID: 33800899
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Smokers' perceptions of different classes of cigarette brand descriptors.
Authors: Felicione N.J. , Norton K.J. , Bansal-Travers M. , Rees V.W. , Cummings K.M. , O'Connor R.J. .
Source: Tobacco prevention & cessation, 2021; 7, p. 9.
EPub date: 2021-02-09.
PMID: 33575516
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The impact of menthol flavoring in combusted tobacco on alternative product purchasing: A pilot study using the Experimental Tobacco Marketplace.
Authors: Denlinger-Apte R.L. , Cassidy R.N. , Carey K.B. , Kahler C.W. , Bickel W.K. , O'Connor R. , Thussu S. , Tidey J.W. .
Source: Drug and alcohol dependence, 2021-01-01; 218, p. 108390.
EPub date: 2020-11-01.
PMID: 33213974
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Impact of Cigarette Filter Ventilation on U.S. Smokers' Perceptions and Biomarkers of Exposure and Potential Harm.
Authors: Carroll D.M. , Stepanov I. , O'Connor R. , Luo X. , Cummings K.M. , Rees V.W. , Bickel W.K. , Berman M.L. , Ashley D.L. , Bansal-Travers M. , et al. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2021 01; 30(1), p. 38-44.
EPub date: 2020-10-22.
PMID: 33093163
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Tobacco harm reduction: Past history, current controversies and a proposed approach for the future.
Authors: Hatsukami D.K. , Carroll D.M. .
Source: Preventive medicine, 2020 11; 140, p. 106099.
EPub date: 2020-04-23.
PMID: 32335031
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Development and Piloting Testing of an Experimental Tobacco and Nicotine Product Marketplace.
Authors: Carroll D.M. , Strayer L. , Nardone N. , Pacek L.R. , Kozink R.V. , Tessier K. , McClernon J. , Benowitz N. , Bickel W.K. , Hatsukami D. .
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2020-06-12; 22(7), p. 1230-1234.
PMID: 31603515
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Worry about lung cancer is related to numeracy and risk perception of diseases associated with smoking.
Authors: Diaz D. , Fix B. , Caruso R. , Bansal-Travers M. , O'Connor R.J. .
Source: American journal of health education, 2020; 51(1), p. 14-21.
EPub date: 2019-12-18.
PMID: 33042323
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Comprehensive Chemical Characterization of Natural American Spirit Cigarettes.
Authors: Jain V. , Alcheva A. , Huang D. , Caruso R. , Jain A. , Lay M. , O'Connor R. , Stepanov I. .
Source: Tobacco regulatory science, 2019 Jul; 5(4), p. 381-399.
PMID: 33907702
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Biomarkers of Exposure and Potential Harm among Natural American Spirit Smokers.
Authors: Carroll D.M. , Allenzara A. , Jensen J. , Stepanov I. , Hecht S. , Murphy S. , Luo X. , Donny E. , Hatsukami D.K. .
Source: Tobacco regulatory science, 2019 Jul; 5(4), p. 339-351.
PMID: 33457467
Related Citations

A Bayesian hierarchical model for demand curve analysis.
Authors: Ho Y.Y. , Nhu Vo T. , Chu H. , Luo X. , Le C.T. .
Source: Statistical methods in medical research, 2018 07; 27(7), p. 2038-2049.
EPub date: 2016-10-20.
PMID: 29846147
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Substitutability of nicotine alone and an electronic cigarette liquid using a concurrent choice assay in rats: A behavioral economic analysis.
Authors: Smethells J.R. , Harris A.C. , Burroughs D. , Hursh S.R. , LeSage M.G. .
Source: Drug and alcohol dependence, 2018-04-01; 185, p. 58-66.
EPub date: 2018-02-05.
PMID: 29427916
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Assessing the Impact of Conflicting Health Warning Information on Intentions to Use E-Cigarettes -An Application of the Heuristic-Systematic Model.
Authors: Katz S.J. , Erkkinen M. , Lindgren B. , Hatsukami D. .
Source: Journal of health communication, 2018; 23(10-11), p. 874-885.
EPub date: 2018-10-25.
PMID: 30358500
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