Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

Conditions
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Nicotine Dependence, Alcohol Dependence

Intervention / Treatment
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* Drug: Topiramate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Topiramate<br>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. | Drug: Topiramate<br>* Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).<br>* Other names: Topamax;|
| Placebo Comparator: Placebo<br>90 participants, will receive matching placebo | Drug: Placebo<br>* Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-week Continuous Abstinence From Smoking | 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. | Weeks 8-12 of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Relapsing to Any Drinking or Illicit Drug Use | Alcohol or illicit drug use during treatment or follow up. | 12-week treatment phase, 36-week combined treatment and follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco use disorders, alcoholism