Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: December 3, 2008
Last updated: May 13, 2015
Last verified: May 2015
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.

Condition Intervention Phase
Nicotine Dependence
Alcohol Dependence
Drug: Topiramate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 4-week continuous abstinence from smoking [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent relapsing to any drinking [ Time Frame: 12-week treatment phase, 36-week combined treatment and follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
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: Arm 2
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.

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.

Ages Eligible for Study:   18 Years to 70 Years
Genders 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development Identifier: NCT00802412     History of Changes
Other Study ID Numbers: NEUA-003-08S 
Study First Received: December 3, 2008
Last Updated: May 13, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Anti-Obesity Agents
Neuroprotective Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016