Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

Study Overview
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Brief Summary
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The extent of toxicity varies considerably across different brands of smokeless tobacco (ST) products and data suggest that greater toxicity may result in greater health risks. However, little is known about the actual extent of exposure to toxicants from current smokeless tobacco products and factors that might moderate the extent of this exposure. The goals of this project are to address the following questions: What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior; What are novel and the best measures of smokeless tobacco use, behavior and exposure; and What are some of the determinants of smokeless tobacco use.

Detailed Description
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Study 1 is a multi-site descriptive study assessing tobacco toxicants in various smokeless tobacco products and tobacco toxicant exposure found in 600 subjects in three sites: University of MN Twin Cities, Oregon Research Institute in Eugene OR, and at West Virginia University in Morgantown, WV (200 subjects per site). The study will examine the relationship between brands of U.S. smokeless tobacco products that contain different levels of tobacco-specific nitrosamines (TSNAs), other carcinogens and nicotine, and biomarkers of exposure and effects on health (e.g., cardiovascular risk factors). Additionally, the study will examine factors that influence the extent of toxicant exposure and effect besides the levels of toxicants in the product. Subjects will attend an orientation where they will sign a consent form and then return for one clinic visit where they will provide blood (UMN only), urine samples, buccal samples and expectorated chews to be examined for nicotine levels, toxicant exposure and potential for tobacco-related health risks. A subsample of subjects (10 per brand of smokeless tobacco) will be asked for a tin of their unused product for testing (they will be reimbursed for the cost of their tin) and will be asked for three samples of expectorated chews that will be collected, frozen and shipped to the CDC where they will be analyzed for tobacco constituents. Subjects will complete several questionnaires on their tobacco use history, alcohol, diet, physical and mental health. Subjects will also keep a daily diary of their tobacco and alcohol use.

Official Title
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Toxicant Exposure Across Brands of Smokeless Tobacco

Conditions
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Smokeless Tobacco Use, Tobacco Dependence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Using a consistent and daily amount of ST for the past year; In good physical health (no unstable medical condition); Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria). Exclusion Criteria: Subjects must not be currently using other tobacco or nicotine products. Female subjects cannot be pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands | Two important harmful constituents in smokeless tobacco products are NNN + NNK, µg/g This measure reports the tobacco-specific nitrosamines (TSNA), N'-nitrosonornicotine (NNN), and 4- (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) across 7 different smokeless tobacco brands. | Three usual dip sized samples were collected from subjects at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smokeless Tobacco, Biomarkers of tobacco exposure