Principal Investigator: Dorothy K. Hatsukami
Funding Mechanism: National Institutes of Health- Grant
ID number: 1U19CA157345-01A1
Award Date: 6/6/2012
Institution: University of Minnesota
The tobacco industry is introducing several potential "modified risk" tobacco products (MRTPs) that can be promoted to be safer or less addictive than conventional products, but scientific methodologies to evaluate these claims are lacking. The overall goal of this research effort is to provide scientists and regulatory agencies with scientifically-based guidelines for methods and measures to assess tobacco products and to test a framework for product evaluation. This five-year research effort will involve four interrelated projects. Project 1 will examine the abuse liability of aqueous tobacco extracts from four different MRTPs and a conventional product in an animal model; these extracts provide an extensive range of nicotine and other tobacco constituents to more closely model actual product exposure in humans. Project 2 will use three abuse liability assessment methods (i.e., human laboratory, ecological assessment, and questionnaire) to evaluate tobacco product demand when the product(s) vary in price; up to 360 cigarette smokers will be recruited for this study. Project 3 will evaluate various aspects of consumer perceptions of new oral tobacco products. Consumer perceptions include reactions to messaging (i.e., knowledge, attitudes, beliefs, product expectancies and risk perceptions) and to product response and use (i.e., behavioral, sensory and other subjective effects); study subjects will include 3,000 subjects per year for a Web survey, 180 participants for an advertising evaluation study incorporating individual-level data collection and group discussion, and 690 current smokers participating in a one-week trial of Camel Snus. Project 4, a human clinical trial of Camel Snus, will assess tobacco product use and its effects on toxicant exposure in 690 subjects randomized to one of five experimental conditions for a period of 8 weeks. This research effort will produce 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, and will enhance understanding of how product characteristics, product abuse liability, consumer perceptions, and moderating influences (i.e., sex, age, race/ethnicity) affect product uptake and use and resulting toxicant exposure.