Status:
COMPLETED
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Lead Sponsor:
VA Office of Research and Development
Conditions:
Nicotine Dependence
Alcohol Dependence
Eligibility:
MALE
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
Detailed Description
This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. Another aim of th...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00802412
Start Date
January 1 2009
End Date
June 1 2015
Last Update
January 31 2017
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161