Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
This trial is active, not recruiting.
|Conditions||nicotine dependence, alcohol dependence|
|Sponsor||Department of Veterans Affairs|
|Start date||January 2009|
|End date||November 2014|
|Trial size||150 participants|
|Trial identifier||NCT00802412, NEUA-003-08S|
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
4-week continuous abstinence from smoking
time frame: End of treatment
Percent relapsing to any drinking
time frame: 12-week treatment phase, 36-week combined treatment and follow-up
Male participants from 18 years up to 70 years old.
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).
|Official title||Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men|
|Principal investigator||Robert M. Anthenelli, MD|
|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 the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). Following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.|
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