Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

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 Anthenelli, MD, Principal Investigator, Affiliation: Cincinnati VA Medical Center

Overall contact:
Kerri M Earles, Phone: (513) 861-3100, Ext: 5507, Email: kerri.earles@va.gov

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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: 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 (1-12 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;

5. have a body mass index [BMI] 18 kg/m2.

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 current, independent mood or anxiety disorder or lifetime psychotic disorder diagnosis;

4. have a history of known hypersensitivity to topiramate;

5. in the investigator's judgment, pose a current suicidal or homicidal risk;

6. have taken other psychotropic drugs (including MAO inhibitors, other antidepressants, anticonvulsants) or smoking cessation aids (NRT, bupropion SR, or varenicline) within 2 months of baseline;

7. have taken any investigational drug within 30 days of baseline;

8. have taken other pharmacotherapies for alcoholism (i. e., disulfiram, naltrexone, acamprosate) within 90 days of baseline; and

9. have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).

Kerri M Earles, Phone: (513) 861-3100, Ext: 5507, Email: kerri.earles@va.gov

VA Medical Center, Cincinnati, Cincinnati, Ohio 45220, United States; Recruiting
Robert Anthenelli, MD, Phone: 513-861-3100, Ext: 4194, Email: robert.anthenelli@va.gov
Kerri M Earles, Phone: (513) 861-3100, Ext: 5507, Email: kerri.earles@va.gov
Robert Anthenelli, MD, Principal Investigator

Starting date: January 2009
Ending date: September 2013
Last updated: September 8, 2009