- Male or female daily smokeless tobacco users aged 18 years and older, who are
motivated to stop use of all tobacco products.
- Subjects must be daily users of nicotine containing smokeless tobacco and using
smokeless tobacco on at least 8 occasions per day averaged over a week.
- Have used smokeless tobacco for at least 1 year prior to screening with no period of
abstinence >3 months in the past year.
- Subjects using nicotine containing products (including smoking tobacco) other than
smokeless tobacco for 3 months prior to screening.
- Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.
- Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
- Subjects currently or within the past 12 months requiring treatment for depression or
have a current or prior history of panic disorder, psychosis, bipolar disorder or any
other serious mental illness.