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Tobacco Constituents and Biomarkers

Smoking Clinical Trial

Official title:
Constituent Yields and Biomarkers of Exposure for Tobacco Product Regulation

Clinical Trial Summary

This proposal addresses several research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products as mandated by the Family Smoking Prevention and Tobacco Control Act. Scientific evidence supports the important role of tobacco and cigarette smoke carcinogens in the development of cancers associated with cigarette smoking. Regulation of the levels of harmful constituents in cigarette smoke is one of the tobacco control strategies that now can be employed by the FDA and may serve to reduce tobacco carcinogen exposures in those smokers who are unable or unwilling to quit smoking. Such regulation will require a valid and robust approach to the assessment of comparative toxicity and carcinogenicity among various cigarette brands. This proposal will help develop a testing approach that can produce meaningful predictions of changes in human exposure due to changes in constituent levels in cigarette smoke, and hence serve as a reliable measure for product regulation. Thus, the proposed research will generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. The human trial deals with Aims 2 and 3 of this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04090606
Study type Observational
Source Masonic Cancer Center, University of Minnesota
Contact
Status Completed
Phase
Start date December 2013
Completion date March 22, 2021
View Details
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