drugset / Trial / NCT00755716
Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study
Phase 3
Completed
57 enrolled
UConn Health
National Center for Research Resources (NCRR) · collabNational Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2006-04
- Primary completion
- 2008-12
- Completion
- 2013-08
Publications
- Results Oncken C, Arias AJ, Feinn R, Litt M, Covault J, Sofuoglu M, Kranzler HR. Topiramate for smoking cessation: a randomized, placebo-controlled pilot study. Nicotine Tob Res. 2014 Mar;16(3):288-96. doi: 10.1093/ntr/ntt141. Epub 2013 Sep 21.
- Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nicotine patch | Unknown | 21 mg | — |
| Comparator | Topiramate | Small molecule | 200 mg | — |