Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

Inclusion Criteria:

Subjects will be included if they:

1. are 18-65 years of age, inclusive;
2. are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence);
3. are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit;
4. are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs;

Exclusion Criteria:

Subjects will be excluded if they:

1. have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease;
2. have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease;
3. have a history of known hypersensitivity to topiramate;
4. in the investigator's judgment, pose a current suicidal or homicidal risk;
5. have taken any investigational drug within 30 days of baseline; and
6. have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).