NCT00755716

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Placebo (sugar pill)	patients receive
DRUG	Topiramate	25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper
DRUG	Nicotine patch	On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-12-01
• Completion: 2013-08-01
• First posted: 2008-09-19
• Last updated: 2017-08-16
• Results posted: 2017-08-16

Locations

1 site across 1 country: United States