Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

This is a randomized, multi-site trial determining the effects of switching smokeless
tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers
of exposure and patterns of use. ST users will undergo a two week baseline assessment period
and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product
with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9
and 20 weeks.

Inclusion Criteria:

1. Using a consistent and daily amount of ST with specific nicotine and tobacco-specific
nitrosamine (TSNA) levels 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.