Currently, there are 7.7 million smokeless tobacco users in the U.S. Smokeless tobacco use has been associated with increased risk of oral pathologies (including oral cancer), pancreatic cancer, diabetes and other components of the metabolic syndrome, fetal toxicity and possibly cardiovascular disease. The extent of these health risks may be associated with the amount of toxicants in these products and the extent of exposure to these toxicants. Research has shown wide variability in carcinogens as well as nicotine in these products. The WHO Framework Convention on Tobacco Control and the proposed FDA legislative bill for tobacco product regulation have provisions that would require tobacco companies to reduce or eliminate harmful toxicants and to reduce levels of nicotine. However, very little research is available to guide decision makers on the impact of reducing toxicants and nicotine nor do we completely understand factors other than product toxicity that are associated with the extent of toxicant exposure. Two studies are proposed with the following goals: 1) Study 1 will examine brands of U.S. smokeless tobacco (ST) products that contain different levels of tobacco specific nitrosamines (TSNAs), other carcinogens and nicotine on existing and novel biomarkers of exposure and effect. In addition, this study will comprehensively determine factors that moderate the extent of exposure other than the levels of toxicants in these products. These factors include individual, social and environmental influences. Subjects will be recruited from 3 different regions in the U.S. and will be assessed on two different occasions. This study will contribute new information on critical factors associated with toxicant exposure. 2) Study 2 will determine the effects of switching ST users to lower TSNA and high, moderate or low nicotine ST products on pattern of use, biomarkers of exposure and toxicity, and facilitation of abstinence. Subjects will undergo measurements during use of their usual brand of smokeless tobacco and then switch to the assigned product for 12 weeks, with follow-up at week 13 and 26. This study would demonstrate the feasibility and impact of switching ST users to less toxic ST products. Together, these studies will help to guide important policy decisions to reduce the toll of tobacco-related disease.

Public Health Relevance

The proposed studies will inform decision makers of science-based policies that can reduce levels of exposure to smokeless tobacco toxicants in smokeless tobacco users and potentially reduce tobacco-related harm by facilitating cessation. Furthermore, these studies will provide a better understanding of factors other than product constituents in tobacco products that might influence the amount of exposure to toxicants. Finally, the proposed studies will provide measures and methods that can be used to assess tobacco products in the event of tobacco product regulation.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA141531-04
Application #
8327678
Study Section
Special Emphasis Panel (ZCA1-SRRB-C (M2))
Program Officer
Parascandola, Mark
Project Start
2009-09-09
Project End
2015-08-31
Budget Start
2012-09-20
Budget End
2013-08-31
Support Year
4
Fiscal Year
2012
Total Cost
$403,012
Indirect Cost
$115,094
Name
University of Minnesota Twin Cities
Department
Psychiatry
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455