Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Topiramate

Criteria

Inclusion Criteria:

Subjects will be included if they:

• are 18-70 years of age, inclusive;

• are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence);

• are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit;

• are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs;

Exclusion Criteria:

Subjects will be excluded if they:

• have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease;

• have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease;

• have a history of known hypersensitivity to topiramate;

• in the investigator's judgment, pose a current suicidal or homicidal risk;

• have taken any investigational drug within 30 days of baseline; and

• have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).