Clinical trial NCT00802412: Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Official title: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Alcohol Dependence
Keywords: tobacco use disorders
alcoholism
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-12-04
Enrollment: 132
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 4-week Continuous Abstinence From Smoking
timeFrame: Weeks 8-12 of treatment.
Secondary outcomes:
measure: Percent Relapsing to Any Drinking or Illicit Drug Use
timeFrame: 12-week treatment phase, 36-week combined treatment and follow-up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Robert M. Anthenelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anthenelli RM, Heffner JL, Wong E, Tibbs J, Russell K, Isgro M, Dinh E, Wehrle C, Worley MJ, Doran N. A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men. Alcohol Clin Exp Res. 2017 Jan;41(1):197-206. doi: 10.1111/acer.13279. Epub 2016 Dec 28.