This trial is active, not recruiting.

Conditions nicotine dependence, alcohol dependence
Treatments topiramate, placebo
Phase phase 2
Sponsor Department of Veterans Affairs
Start date January 2009
End date November 2014
Trial size 150 participants
Trial identifier NCT00802412, NEUA-003-08S


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
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.
topiramate Topamax
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 Comparator)
90 participants, will receive matching placebo
Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Primary Outcomes

4-week continuous abstinence from smoking
time frame: End of treatment

Secondary Outcomes

Percent relapsing to any drinking
time frame: 12-week treatment phase, 36-week combined treatment and follow-up

Eligibility Criteria

Male participants from 18 years up to 70 years old.

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).

Additional Information

Official title Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
Principal investigator Robert M. Anthenelli, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.