At a glance
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Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study
In Brief
A Phase 3 clinical trial evaluating Placebo (sugar pill), Topiramate, and 1 other intervention for Tobacco Dependence. Completed, enrolled 57 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
patients receive
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
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.