Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

Phase 2

Completed

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

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.

Recruitment & 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).

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate	The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
Placebo	Placebo	90 participants, will receive matching placebo

Primary Outcome Measures

Name	Time	Method
4-week Continuous Abstinence From Smoking	Weeks 8-12 of treatment.	This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.

Secondary Outcome Measures

Name	Time	Method
Percent Relapsing to Any Drinking or Illicit Drug Use	12-week treatment phase, 36-week combined treatment and follow-up	Alcohol or illicit drug use during treatment or follow up.