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Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

Tobacco Dependence Clinical Trial

Official title:
Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

Clinical Trial Summary

Specific aims:

1. To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of treatment with topiramate or placebo or topiramate plus nicotine patch for smoking cessation.

2. To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking satisfaction, and adverse effects during smoking cessation.

3. To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus combination of topiramate plus nicotine patch for smoking cessation.

Clinical Trial Description

This is a 10-week, randomized, double-blind, single-site study of treatment with either: topiramate, or placebo, or topiramate plus nicotine patch. Approximately, 90 subjects ages 18-65 who smoke at least 10 cigarettes per day will be screened for study participation, with the intention of 60 subjects being eligible for randomized treatment (20 per arm). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00755716
Study type Interventional
Source UConn Health
Contact
Status Completed
Phase Phase 3
Start date April 2006
Completion date August 2013
View Details
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