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Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nicotine Dependence; Alcohol Dependence

Intervention: Topiramate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Robert M. Anthenelli, MD, Principal Investigator, Affiliation: VA San Diego Healthcare System, San Diego, CA


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

Clinical Details

Official title: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 4-week continuous abstinence from smoking

Secondary outcome: Percent relapsing to any drinking

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 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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.


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).

Locations and Contacts

VA San Diego Healthcare System, San Diego, CA, San Diego, California 92161, United States
Additional Information

Click here for more information about this study: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

Starting date: January 2009
Last updated: May 13, 2015

Page last updated: August 23, 2015

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