Grant Number:	4U19CA157345-05 Interpret this number
Primary Investigator:	Hatsukami, Dorothy
Organization:	University Of Minnesota
Project Title:	Models for Tobacco Product Evaluation
Fiscal Year:	2016

DESCRIPTION (provided by applicant): In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (FSPTCA) which gave the Food and Drug Administration (FDA) regulatory authority over tobacco products. Under this law the FDA is required to evaluate new and modified tobacco products for their effects on a population wide-basis. Yet, there is limited knowledge on the measures and methods that should be used to evaluate these products. What is needed now are reliable and valid measures and methods that regulators can use to predict in advance how consumers are likely to respond (i.e., use leading to exposure) to new and modified tobacco products. This P01 builds on our previous NCI contract [N01PC644202], which proposed a comprehensive framework for evaluating tobacco products. This P01 attempts to test elements of that framework by conducting a series of interrelated studies designed to assess the potential uptake and dependence of a new oral tobacco product and resulting toxicant exposure in current cigarette smokers. To date, no systematic and comprehensive studies have been conducted to validate methods and measures for tobacco product evaluation. Specifically, Projects 1 and 2 will evaluate methods and measures to assess the relative abuse liability of tobacco products in animals and in humans. Project 3 seeks to understand and assess various aspects of consumer perception of tobacco products, and Project 4 assesses tobacco product use and its effects on exposure to toxicants in the context of a clinical trial. In addition to these Projects, we have an Administrative Core (Core A ) responsible for supporting the administration of the grant, facilitating collaboration, assuring the quality and timeliness of our science, integrating the results from the Projects and translating our research findings into potential policies; a Tobacco Constituent and Biomarker Core (Core B) that will be responsible for providing constituent analysis and analyzing our samples for carcinogen biomarkers of exposure and effect, and establishing a biorepository; a Biostatistics and Informatics Core (Core C) responsible for database development and management, statistical analysis for each of the projects, and coordinating data analysis across projects. At the conclusion of this P01 we will have produced evidence on the reliability and validity of an array of methods and measures that can be applied to predict how consumers are likely to use and abuse new and modified tobacco products. The findings from this study should directly influence the kinds of methods and measures that FDA and other regulatory groups around the world might apply to evaluating harm reduction potential of new and modified tobacco products. Furthermore, because of the integrative nature of the studies, this P01 will help us understand how product characteristics, product abuse liability and consumer perception of a product and moderating influences (i.e., sex, age, race/ethnicity) affects uptake and use and resulting toxicant exposure.




Perceived Truthfulness of Reduced Lung Cancer Risk Advertising Claims Influences Consumers' Intention to try and to Purchase Snus.
Authors: Fix B.V. , Wackowski O.A. , Sharma A. , Diaz D. , Bansal-Travers M. , Cummings K.M. , Rees V.W. , Hatsukami D.K. , O'Connor R.J. .
Source: Tobacco Use Insights, 2023; 16, p. 1179173X231206042.
EPub date: 2023-10-13 00:00:00.0.
PMID: 37842177
Related Citations

Intention to purchase alternative tobacco products as a function of smoking status and responses to advertising, packaging, and sensory experiences.
Authors: Sharma A. , June K.M. , Norton K.J. , Fix B. , Bansal-Travers M. , Rees V.W. , J O'Connor R. .
Source: Addictive Behaviors, 2022 07; 130, p. 107291.
EPub date: 2022-02-22 00:00:00.0.
PMID: 35220153
Related Citations

β-Carbolines found in cigarette smoke elevate intracranial self-stimulation thresholds in rats.
Authors: Harris A.C. , Muelken P. , LeSage M.G. .
Source: Pharmacology, Biochemistry, And Behavior, 2020 Nov; 198, p. 173041.
EPub date: 2020-09-11 00:00:00.0.
PMID: 32926882
Related Citations

A Randomized Clinical Trial Examining the Effects of Instructions for Electronic Cigarette Use on Smoking-Related Behaviors and Biomarkers of Exposure.
Authors: Hatsukami D.K. , Meier E. , Lindgren B.R. , Anderson A. , Reisinger S.A. , Norton K.J. , Strayer L. , Jensen J.A. , Dick L. , Murphy S.E. , et al. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2020-08-24 00:00:00.0; 22(9), p. 1524-1532.
PMID: 31828315
Related Citations

Smokers Awareness and Risk Perceptions of Filter Ventilation.
Authors: Caruso R.V. , Fix B.V. , Ingabire M.J. , Bansal-Travers M. , Rees V.W. , Cummings K.M. , Shields P.G. , Hatsukami D.K. , O'Connor R.J. .
Source: Tobacco Regulatory Science, 2020 May; 6(3), p. 213-223.
PMID: 38957357
Related Citations

The role of subjective responses in electronic cigarette uptake and substitution in adult smokers.
Authors: Gades M.S. , Petersen A. , Meier E. , Lindgren B.R. , O'Connor R.J. , Shields P.G. , Hatsukami D. .
Source: Drug And Alcohol Dependence, 2020-04-25 00:00:00.0; , p. 107999.
EPub date: 2020-04-25 00:00:00.0.
PMID: 32409110
Related Citations

A Randomized Clinical Trial of Snus Examining the Effect of Complete Versus Partial Cigarette Substitution on Smoking-Related Behaviors, and Biomarkers of Exposure.
Authors: Meier E. , Lindgren B.R. , Anderson A. , Reisinger S.A. , Norton K.J. , Jensen J. , Strayer L. , Dick L. , Tang M.K. , Chen M. , et al. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2020-04-17 00:00:00.0; 22(4), p. 473-481.
PMID: 31321423
Related Citations

Applying tobacco, environmental and dietary-related biomarkers to understand cancer etiology and evaluate prevention strategies.
Authors: Peterson L.A. , Balbo S. , Fujioka N. , Hatsukami D.K. , Hecht S.S. , Murphy S.E. , Stepanov I. , Tretyakova N. , Turesky R.J. , Villalta P.W. .
Source: Cancer Epidemiology, Biomarkers & Prevention : A Publication Of The American Association For Cancer Research, Cosponsored By The American Society Of Preventive Oncology, 2020-02-12 00:00:00.0; , .
EPub date: 2020-02-12 00:00:00.0.
PMID: 32051197
Related Citations

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 00:00:00.0.
PMID: 33042323
Related Citations

Tobacco-Related Alterations in Airway Gene Expression are Rapidly Reversed Within Weeks Following Smoking-Cessation.
Authors: Hijazi K. , Malyszko B. , Steiling K. , Xiao X. , Liu G. , Alekseyev Y.O. , Dumas Y.M. , Hertsgaard L. , Jensen J. , Hatsukami D. , et al. .
Source: Scientific Reports, 2019-05-06 00:00:00.0; 9(1), p. 6978.
EPub date: 2019-05-06 00:00:00.0.
PMID: 31061400
Related Citations

The experimental tobacco marketplace: Narrative influence on electronic cigarette substitution.
Authors: DeHart W.B. , Kaplan B.A. , Pope D.A. , Mellis A.M. , Bickel W.K. .
Source: Experimental And Clinical Psychopharmacology, 2019 Apr; 27(2), p. 115-124.
EPub date: 2018-11-05 00:00:00.0.
PMID: 30394764
Related Citations

The Debate About Nicotine Addiction and the Role of Medicinal Products: Commentary on Zeller.
Authors: Hatsukami D.K. , Donny E.C. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2019-02-18 00:00:00.0; 21(3), p. 338-339.
PMID: 30312443
Related Citations

Electronic cigarette substitution in the experimental tobacco marketplace: A review.
Authors: Bickel W.K. , Pope D.A. , Kaplan B.A. , DeHart W.B. , Koffarnus M.N. , Stein J.S. .
Source: Preventive Medicine, 2018 12; 117, p. 98-106.
EPub date: 2018-04-24 00:00:00.0.
PMID: 29702131
Related Citations

Propylene glycol, a major electronic cigarette constituent, attenuates the adverse effects of high-dose nicotine as measured by intracranial self-stimulation in rats.
Authors: Harris A.C. , Muelken P. , Haave Z. , Swain Y. , Smethells J.R. , LeSage M.G. .
Source: Drug And Alcohol Dependence, 2018-12-01 00:00:00.0; 193, p. 162-168.
EPub date: 2018-10-18 00:00:00.0.
PMID: 30384324
Related Citations

Delay discounting and e-cigarette use: An investigation in current, former, and never cigarette smokers.
Authors: Stein J.S. , Heckman B.W. , Pope D.A. , Perry E.S. , Fong G.T. , Cummings K.M. , Bickel W.K. .
Source: Drug And Alcohol Dependence, 2018-10-01 00:00:00.0; 191, p. 165-173.
EPub date: 2018-08-11 00:00:00.0.
PMID: 30121475
Related Citations

Effects of Filter Ventilation on Behavioral Economic Demand for Cigarettes: A Preliminary Investigation.
Authors: Stein J.S. , Koffarnus M.N. , O'Connor R.J. , Hatsukami D.K. , Bickel W.K. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2018-09-04 00:00:00.0; 20(10), p. 1278-1282.
PMID: 29065197
Related Citations

Status and Future Directions of Preclinical Behavioral Pharmacology in Tobacco Regulatory Science.
Authors: LeSage M.G. , Smethells J.R. , Harris A.C. .
Source: Behavior Analysis (washington, D.c.), 2018 Aug; 18(3), p. 252-274.
EPub date: 2018-07-09 00:00:00.0.
PMID: 30214916
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 Jul; 27(7), p. 2038-2049.
EPub date: 2016-10-20 00:00:00.0.
PMID: 29846147
Related Citations

Cigarette and e-liquid demand and substitution in e-cigarette-naïve smokers.
Authors: Stein J.S. , Koffarnus M.N. , Stepanov I. , Hatsukami D.K. , Bickel W.K. .
Source: Experimental And Clinical Psychopharmacology, 2018 Jun; 26(3), p. 233-243.
PMID: 29863381
Related Citations

Whether to push or pull? Nicotine reduction and non-combusted alternatives - Two strategies for reducing smoking and improving public health.
Authors: Smith T.T. , Hatsukami D.K. , Benowitz N.L. , Colby S.M. , McClernon F.J. , Strasser A.A. , Tidey J.W. , White C.M. , Donny E.C. .
Source: Preventive Medicine, 2018-03-29 00:00:00.0; , .
EPub date: 2018-03-29 00:00:00.0.
PMID: 29604326
Related Citations

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, 2018-02-05 00:00:00.0; 185, p. 58-66.
EPub date: 2018-02-05 00:00:00.0.
PMID: 29427916
Related Citations

Effects of isolated tobacco alkaloids and tobacco products on deprivation-induced food intake and meal patterns in rats.
Authors: Bunney P.E. , Hansen M. , LeSage M. .
Source: Pharmacology, Biochemistry, And Behavior, 2018 Feb; 165, p. 45-55.
EPub date: 2017-11-28 00:00:00.0.
PMID: 29196096
Related Citations

Effects of nicotine-containing and "nicotine-free" e-cigarette refill liquids on intracranial self-stimulation in rats.
Authors: Harris A.C. , Muelken P. , Smethells J.R. , Yershova K. , Stepanov I. , Olson T.T. , Kellar K.J. , LeSage M.G. .
Source: Drug And Alcohol Dependence, 2018-02-01 00:00:00.0; 185, p. 1-9.
EPub date: 2018-02-01 00:00:00.0.
PMID: 29413432
Related Citations

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 00:00:00.0.
PMID: 30358500
Related Citations

Evaluation of modified risk claim advertising formats for Camel Snus.
Authors: Fix B.V. , Adkison S.E. , O'Connor R.J. , Bansal-Travers M. , Cummings K.M. , Rees V.W. , Hatsukami D.K. .
Source: Health Education Journal, 2017 Dec; 76(8), p. 971-985.
EPub date: 2017-09-20 00:00:00.0.
PMID: 38974785
Related Citations

Similar precipitated withdrawal effects on intracranial self-stimulation during chronic infusion of an e-cigarette liquid or nicotine alone.
Authors: Harris A.C. , Muelken P. , Smethells J.R. , Krueger M. , LeSage M.G. .
Source: Pharmacology, Biochemistry, And Behavior, 2017 Oct; 161, p. 1-5.
EPub date: 2017-09-01 00:00:00.0.
PMID: 28867606
Related Citations

E-cigarettes Warning Labels and Modified Risk Statements: Tests of Messages to Reduce Recreational Use.
Authors: Katz S.J. , Lindgren B. , Hatsukami D. .
Source: Tobacco Regulatory Science, 2017 Oct; 3(4), p. 445-458.
PMID: 30238022
Related Citations

21st century neurobehavioral theories of decision making in addiction: Review and evaluation.
Authors: Bickel W.K. , Mellis A.M. , Snider S.E. , Athamneh L.N. , Stein J.S. , Pope D.A. .
Source: Pharmacology, Biochemistry, And Behavior, 2017-09-21 00:00:00.0; , .
EPub date: 2017-09-21 00:00:00.0.
PMID: 28942119
Related Citations

Tobacco product use patterns, nicotine and tobacco-specific nitrosamine exposure: NHANES 1999-2012.
Authors: Choi K. , Sabado M. , El-Toukhy S. , Vogtmann E. , Freedman N.D. , 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, 2017-07-14 00:00:00.0; , .
EPub date: 2017-07-14 00:00:00.0.
PMID: 28710077
Related Citations

Internalized smoking stigma in relation to quit intentions, quit attempts, and current e-cigarette use.
Authors: O'Connor R.J. , Rees V.W. , Rivard C. , Hatsukami D.K. , Cummings K.M. .
Source: Substance Abuse, 2017 Jul-Sep; 38(3), p. 330-336.
EPub date: 2017-05-08 00:00:00.0.
PMID: 28481713
Related Citations

A Review of Pulmonary Toxicity of Electronic Cigarettes In The Context of Smoking: A Focus On Inflammation.
Authors: Shields P.G. , Berman M. , Brasky T.M. , Freudenheim J.L. , Mathe E.A. , McElroy J. , Song M.A. , Wewers M.D. .
Source: Cancer Epidemiology, Biomarkers & Prevention : A Publication Of The American Association For Cancer Research, Cosponsored By The American Society Of Preventive Oncology, 2017-06-22 00:00:00.0; , .
EPub date: 2017-06-22 00:00:00.0.
PMID: 28642230
Related Citations

Reducing tobacco-related harm: FDA's proposed product standard for smokeless tobacco.
Authors: Berman M.L. , Hatsukami D.K. .
Source: Tobacco Control, 2017-06-20 00:00:00.0; , .
EPub date: 2017-06-20 00:00:00.0.
PMID: 28634163
Related Citations

Will Delay Discounting Predict Intention to Quit Smoking?
Authors: Athamneh L.N. , Stein J.S. , Bickel W.K. .
Source: Experimental And Clinical Psychopharmacology, 2017-06-19 00:00:00.0; , .
EPub date: 2017-06-19 00:00:00.0.
PMID: 28627925
Related Citations

Behavioral economic substitution between conventional cigarettes and e-cigarettes differs as a function of the frequency of e-cigarette use.
Authors: Snider S.E. , Cummings K.M. , Bickel W.K. .
Source: Drug And Alcohol Dependence, 2017-05-19 00:00:00.0; 177, p. 14-22.
EPub date: 2017-05-19 00:00:00.0.
PMID: 28550711
Related Citations

Perceptions of "Natural" and "Additive-Free" Cigarettes and Intentions to Purchase.
Authors: O'Connor R.J. , Lewis M.J. , Adkison S.E. , Bansal-Travers M. , Cummings K.M. .
Source: Health Education & Behavior : The Official Publication Of The Society For Public Health Education, 2017 04; 44(2), p. 222-226.
EPub date: 2016-07-09 00:00:00.0.
PMID: 27281493
Related Citations

The case for the WHO Advisory Note, Global Nicotine Reduction Strategy.
Authors: Hatsukami D.K. , Zaatari G. , Donny E. .
Source: Tobacco Control, 2017 03; 26(e1), p. e29-e30.
EPub date: 2016-06-29 00:00:00.0.
PMID: 27357938
Related Citations

Reinforcer Pathology: The Behavioral Economics of Abuse Liability Testing.
Authors: Bickel W.K. , Snider S.E. , Quisenberry A.J. , Stein J.S. .
Source: Clinical Pharmacology And Therapeutics, 2017 Feb; 101(2), p. 185-187.
EPub date: 2016-09-19 00:00:00.0.
PMID: 27509043
Related Citations

Reduced Nicotine Content Cigarettes And Use Of Alternative Nicotine Products: Exploratory Trial
Authors: Hatsukami D.K. , Luo X. , Dick L. , Kangkum M. , Allen S.S. , Murphy S.E. , Hecht S.S. , Shields P.G. , al'Absi M. .
Source: Addiction (abingdon, England), 2017 Jan; 112(1), p. 156-167.
PMID: 27614097
Related Citations

Naturalistic Assessment Of Demand For Cigarettes, Snus, And Nicotine Gum
Authors: Stein J.S. , Wilson A.G. , Koffarnus M.N. , Judd M.C. , Bickel W.K. .
Source: Psychopharmacology, 2017 Jan; 234(2), p. 245-254.
PMID: 27730273
Related Citations

Gender Differences In Snus Versus Nicotine Gum For Cigarette Avoidance Among A Sample Of Us Smokers
Authors: Allen A. , Vogel R.I. , Meier E. , Anderson A. , Jensen J. , Severson H.H. , Hatsukami D. .
Source: Drug And Alcohol Dependence, 2016-11-01 00:00:00.0; 168, p. 8-12.
PMID: 27610935
Related Citations

Abuse Liability Assessment Of An E-cigarette Refill Liquid Using Intracranial Self-stimulation And Self-administration Models In Rats
Authors: LeSage M.G. , Staley M. , Muelken P. , Smethells J.R. , Stepanov I. , Vogel R.I. , Pentel P.R. , Harris A.C. .
Source: Drug And Alcohol Dependence, 2016-11-01 00:00:00.0; 168, p. 76-88.
PMID: 27627814
Related Citations

A Two-part Mixed Effects Model For Cigarette Purchase Task Data
Authors: Zhao T. , Luo X. , Chu H. , Le C.T. , Epstein L.H. , Thomas J.L. .
Source: Journal Of The Experimental Analysis Of Behavior, 2016 Nov; 106(3), p. 242-253.
PMID: 27870106
Related Citations

The Return Of Rate Dependence
Authors: Quisenberry A.J. , Snider S.E. , Bickel W.K. .
Source: Behavior Analysis (washington, D.c.), 2016 Nov; 16(4), p. 215-220.
PMID: 28042602
Related Citations

Self-administration Of Smokeless Tobacco Products In Rats
Authors: LeSage M.G. , Burroughs D. , Muelken P. , Harris A.C. .
Source: Tobacco Regulatory Science, 2016 Oct; 2(4), p. 329-342.
PMID: 28239627
Related Citations

Application Of The Smokeless Tobacco Expectancies Questionnaire To Snus
Authors: Adkison S.E. , Bansal-Travers M. , Rees V.W. , Hatsukami D.K. , Cummings K.M. , O'Connor R.J. .
Source: American Journal Of Health Behavior, 2016 Sep; 40(5), p. 652-8.
PMID: 27561868
Related Citations

Novel Therapeutics For Addiction: Behavioral And Neuroeconomic Approaches
Authors: Bickel W.K. , Mellis A.M. , Snider S.E. , Moody L. , Stein J.S. , Quisenberry A.J. .
Source: Current Treatment Options In Psychiatry, 2016 Sep; 3(3), p. 277-292.
PMID: 28018836
Related Citations

The Experimental Tobacco Marketplace I: Substitutability as a Function of the Price of Conventional Cigarettes.
Authors: Quisenberry A.J. , Koffarnus M.N. , Hatz L.E. , Epstein L.H. , Bickel W.K. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2016 07; 18(7), p. 1642-8.
EPub date: 2015-10-15 00:00:00.0.
PMID: 26470723
Related Citations

Some Current Dimensions Of The Behavioral Economics Of Health-related Behavior Change
Authors: Bickel W.K. , Moody L. , Higgins S.T. .
Source: Preventive Medicine, 2016-06-06 00:00:00.0; , .
PMID: 27283095
Related Citations

Behavioral Economics Of Cigarette Purchase Tasks: Within-subject Comparison Of Real, Potentially Real, And Hypothetical Cigarettes
Authors: Wilson A.G. , Franck C.T. , Koffarnus M.N. , Bickel W.K. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2016 May; 18(5), p. 524-30.
PMID: 26187389
Related Citations

Validation Of A Measure Of Normative Beliefs About Smokeless Tobacco Use
Authors: Adkison S.E. , O'Connor R.J. , Bansal-Travers M. , Cummings K.M. , Rees V.W. , Hatsukami D.K. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2016 May; 18(5), p. 801-8.
PMID: 26187390
Related Citations