- Male and female cigarette smokers over the age of 18 years who are not willing/able to
quit smoking within the next month but who are willing to attempt to reduce their
smoking to work toward a quit attempt within the next 3 months.
- Subjects must have smoked an average of at least 10 cigarettes per day during the past
year and during the month prior to the screening visit, with no continuous period of
abstinence greater than 3 months in the past year and who have an exhaled carbon
monoxide (CO) >10 ppm at screening.
- Subjects with mild to moderate depression or anxiety may be included if their
condition is stable.
- Subjects with a history of a suicide attempt or any suicidal behavior in the past two
- Subjects with severe depression or anxiety.
- Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress
disorder (PTSD), or schizophrenia.
- Subjects with alcohol or substance abuse or dependence (except nicotine) unless in
full remission for at least 12 months.