Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

• ClinicalTrials.gov Identifier: NCT00802412
• Recruitment Status: Completed
• First Posted: December 4, 2008
• Results First Posted: January 31, 2017
• Last Update Posted: January 31, 2017
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

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.

Eligibility Criteria

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

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).

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Robert M. Anthenelli, MD; VA San Diego Healthcare System, San Diego, CA

More Information

Additional Information:

Click here for more information about this study: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00802412
• Other Study ID Numbers: NEUA-003-08S
• First Posted: December 4, 2008
• 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; alcoholism

Additional relevant MeSH terms:

Alcoholism; Tobacco Use Disorder; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Topiramate; Anticonvulsants; Hypoglycemic Agents; Physiological Effects of Drugs