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 th 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.
The overall goal of this P01 proposal is to provide scientists and regulatory agencies scientifically-based guidelines for methods and measures to assess tobacco products and to test a framework for the evaluation of tobacco products.
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