Nicotine Dependence Clinical Trial
Official title:
Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
Verified date | May 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | June 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 4-week continuous abstinence from smoking | End of treatment | No | |
Secondary | Percent relapsing to any drinking | 12-week treatment phase, 36-week combined treatment and follow-up | No |
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