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Tobacco Constituents and Biomarkers

NCT04090606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2021-08-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2021-03-22
Completion
2021-03-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090606 on ClinicalTrials.gov