The U.S. tobacco marketplace is changing fast, and regulatory science lags far behind. The FDA can alter this dynamic, but needs the tools to do so. One necessary tool is a model for evaluating all types of """"""""modified risk tobacco products"""""""" (MRTPs): novel tobacco products marketed with the claim that they reduce harm or risk associated with conventional products. There are few demonstrated models for predicting tobacco product harm or risk, which demands an understanding of MRTP constituents using analytic lab methods, toxicant exposure and abuse liability using human lab methods, longer-term effects using randomized control trial (RCT) methods, and attitudes, beliefs, and perceived effects using quantitative and qualitative methods. The overarching goal of the Center for the Study of Tobacco Products is to demonstrate empirically an integrated, iterative MRTP evaluation model that uses all of these methods to inform tobacco product regulation across all product types (combustible, oral, or vapor). The Center unites NIH-funded scientist/educators from multiple disciplines to demonstrate the transdisciplinary MRTP evaluation model. We begin with an evaluation of """"""""electronic cigarettes"""""""" (EClGs), novel tobacco products that are marketed now and increasingly popular. EClGs offer an opportunity to demonstrate how the model we propose can inform regulatory policy. To meet the Center's overarching goal we describe four integrated, multi-year projects that aim to: 1) Examine factors that influence MRTP nicotine and toxicant yield;2) Compare short-term effects of MRTPs to other products in the human lab;3) Characterize effects of real-world MRTP use in the natural environment using RCT methods;and 4) Study the influence MRTP use and misuse on user attitudes, beliefs, and perceived effects using qualitative and quantitative methods. An Administrative Core will facilitate financia and managerial processes, provide data management and biostatistical support, co-ordinate communication within and across centers, and interface with scientists and policymakers. A Training and Education Core will develop a course on transdisciplinary methods for evaluating products and will support up to 4 pre-doctoral and 4 postdoctoral appointees. Finally, a pilot research program will solicit and fund innovative projects from our Virginia-wide network of scientists and respond to emerging products of any type. The Center is thus structured to address FDA needs and operate collaboratively. Overall, this Center will provide the expertise, innovation, infrastructure, and information necessary for the sustained success of FDA's mandate to regulate novel tobacco products, including MRTPs.

Public Health Relevance

This Center is designed to inform tobacco regulatory science and thereby contribute to public health. The four projects will answer important questions about electronic cigarettes while giving the Food and Drug Administration an empirical demonstration of a transdisciplinary, integrated, iterative, MRTP evaluation model. The Center thus provides FDA necessary scientific tools to ensure that only those novel tobacco products that have positive public health effects are marketed.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Specialized Center (P50)
Project #
5P50DA036105-02
Application #
8737830
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Kautz, Mary A
Project Start
2013-09-30
Project End
2018-08-31
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Virginia Commonwealth University
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
Hobkirk, Andréa L; Nichols, Travis T; Foulds, Jonathan et al. (2018) Changes in resting state functional brain connectivity and withdrawal symptoms are associated with acute electronic cigarette use. Brain Res Bull 138:56-63
Jawad, Mohammed; Eissenberg, Thomas; Salman, Rola et al. (2018) Toxicant inhalation among singleton waterpipe tobacco users in natural settings. Tob Control :
Bahelah, Raed; Ward, Kenneth D; Ben Taleb, Ziyad et al. (2018) Determinants of progression of nicotine dependence symptoms in adolescent waterpipe smokers. Tob Control :
Veldheer, Susan; Yingst, Jessica; Midya, Vishal et al. (2018) Pulmonary and other health effects of electronic cigarette use among adult smokers participating in a randomized controlled smoking reduction trial. Addict Behav :
Cobb, Caroline O; Soule, Eric K; Rudy, Alyssa K et al. (2018) Patterns and Correlates of Tobacco and Cannabis co-use by Tobacco Product Type: Findings from the Virginia Youth Survey. Subst Use Misuse 53:2310-2319
Dawkins, Lynne; Cox, Sharon; Goniewicz, Maciej et al. (2018) 'Real-world' compensatory behaviour with low nicotine concentration e-liquid: subjective effects and nicotine, acrolein and formaldehyde exposure. Addiction 113:1874-1882
Curry, Zachary A; Wilkerson, Jenny L; Bagdas, Deniz et al. (2018) Monoacylglycerol Lipase Inhibitors Reverse Paclitaxel-Induced Nociceptive Behavior and Proinflammatory Markers in a Mouse Model of Chemotherapy-Induced Neuropathy. J Pharmacol Exp Ther 366:169-183
Gibson, Laura A; Creamer, MeLisa R; Breland, Alison B et al. (2018) Measuring perceptions related to e-cigarettes: Important principles and next steps to enhance study validity. Addict Behav 79:219-225
Wall, Catherine S; Bono, Rose S; Lester, Rebecca C et al. (2018) Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol. BMJ Open 8:e023850
El-Hage, Rachel; El-Hellani, Ahmad; Salman, Rola et al. (2018) Fate of pyrazines in the flavored liquids of e-cigarettes. Aerosol Sci Technol 52:377-384

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