Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-06-30

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.

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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.

Conditions

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Nicotine Dependence Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

Topiramate

Intervention Type DRUG

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).

Placebo

90 participants, will receive matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Interventions

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Topiramate

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).

Intervention Type DRUG

Placebo

Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Intervention Type DRUG

Other Intervention Names

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Topamax

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No