Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

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.

Inclusion Criteria:

1. Using a consistent and daily amount of ST for the past year;

2. In good physical health (no unstable medical condition);

3. 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:

1. Subjects must not be currently using other tobacco or nicotine products.

2. Female subjects cannot be pregnant or nursing.