Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00802412
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Alcohol Dependence Drug: Topiramate Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
Study Start Date : January 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arm Intervention/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.
Drug: 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).
Other Name: Topamax

Placebo Comparator: Placebo
90 participants, will receive matching placebo
Drug: Placebo
Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Primary Outcome Measures :
  1. 4-week Continuous Abstinence From Smoking [ Time Frame: Weeks 8-12 of treatment. ]
    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.

Secondary Outcome Measures :
  1. Percent Relapsing to Any Drinking or Illicit Drug Use [ Time Frame: 12-week treatment phase, 36-week combined treatment and follow-up ]
    Alcohol or illicit drug use during treatment or follow up.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00802412

United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Robert M. Anthenelli, MD VA San Diego Healthcare System, San Diego, CA

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00802412     History of Changes
Other Study ID Numbers: NEUA-003-08S
First Posted: December 4, 2008    Key Record Dates
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017
Last Verified: December 2016

Keywords provided by VA Office of Research and Development:
tobacco use disorders

Additional relevant MeSH terms:
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents