NCT04090606

Tobacco Constituents and Biomarkers

Constituent Yields and Biomarkers of Exposure for Tobacco Product Regulation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	FTC Method Smoking Regimen	cigarettes are smoked by drawing 35 mL puff volumes over 2 s, with 60 s interval between puffs and no blocking of filter ventilation holes
OTHER	Massachusetts Method Smoking Regimen	45-mL puffs drawn over 2 s, with 30 s interval between puffs and 50% blocking of filter ventilation holes
OTHER	Health Canada Intense Smoking Regimen	55-mL puff volumes of 2-s duration, with 30 s interval between puffs and 100% blocking of filter ventilation holes

Timeline

• Start date: 2013-12-01
• Primary completion: 2021-03-22
• Completion: 2021-03-22
• First posted: 2019-09-16
• Last updated: 2021-08-11