Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Completed · Phase 2 · Has a placebo group
Conditions studied: Nicotine Dependence, Alcohol Dependence
In brief
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
Key facts
- Study ID
- NCT00802412
- Run by
- VA Office of Research and Development
- People needed
- 132
- Starts
- 2009-01-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2017-01-31
Who can join
Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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).
Where it is running
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States
Full record on ClinicalTrials.gov
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