Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

Nicotine Dependence Clinical Trial

Official title:

Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00802412
• Other study ID #: NEUA-003-08S
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 3, 2008
• Last updated: May 13, 2015
• Start date: January 2009
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Nicotine Dependence

Intervention

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).
• Placebo
Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-week continuous abstinence from smoking		End of treatment	No
Secondary	Percent relapsing to any drinking		12-week treatment phase, 36-week combined treatment and follow-up	No

External Links

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