Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence; Alcohol Dependence

Treatments: Drug: Placebo; Drug: Topiramate

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00802412

NEUA-003-08S

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups, including a placebo group

Topiramate

Other group

Description:

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.

Treatment:

Drug: Topiramate

Placebo

Placebo Comparator group

Description:

90 participants, will receive matching placebo

Treatment:

Drug: Placebo