Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nicotine Dependence; Alcohol Dependence
Intervention: Topiramate (Drug); Placebo (Drug)
Phase: Phase 2
Status: 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
Overall contact:
Elizabeth N Dinh, MA, Phone: (858) 642-1026, Email: elizabeth.dinh@va.gov
Summary
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
Subjects will be included if they:
1. are 18-65 years of age, inclusive;
2. are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol
dependence in early full remission (1-36 months abstinence);
3. are current tobacco smokers who smoke an average of 10 or more cigarettes per day in
the two months prior to the screening visit;
4. are motivated to try to quit smoking and maintain abstinence from alcohol and other
illicit drugs;
Exclusion Criteria:
Subjects will be excluded if they:
1. have any clinically significant laboratory evidence of hematologic, hepatic,
cardiovascular, renal, pulmonary, or thyroid disease;
2. have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary,
metabolic, cardiovascular, infectious, or endocrine disease;
3. have a history of known hypersensitivity to topiramate;
4. in the investigator's judgment, pose a current suicidal or homicidal risk;
5. have taken any investigational drug within 30 days of baseline; and
6. have a current seizure disorder or a history of severe alcohol withdrawal (alcohol
withdrawal seizures, hallucinations / illusions, delirium tremens).
Locations and Contacts
Elizabeth N Dinh, MA, Phone: (858) 642-1026, Email: elizabeth.dinh@va.gov
VA San Diego Healthcare System, San Diego, CA, San Diego, California 92161, United States; Recruiting
Robert M Anthenelli, MD, Phone: 513-861-3100, Ext: 4914, Email: robert.anthenelli@va.gov
Elizabeth N Dinh, MA, Phone: (858) 642-1026, Email: elizabeth.dinh@va.gov
Robert M. Anthenelli, MD, Principal Investigator
Additional Information
Starting date: January 2009
Last updated: November 29, 2012
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