drugset

drugset / Trial / NCT00802412

Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

NCT00802412 ↗

Phase 2 Completed 132 enrolled VA Office of Research and Development

RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start: 2009-01
Primary completion: 2014-11
Completion: 2015-06

Outcome

Missed primary endpoint

paper cessation rate was similar to placebo (10.6%; odds ratio = 1.60; 95% confidence interval 0.4, 6.5; p = 0.51). PMID 28029173 ↗

paper had no effects on smoking cessation or the prevention of alcohol or drug relapse PMID 28029173 ↗

Publications

Anthenelli RM, Heffner JL, Wong E, Tibbs J, Russell K, Isgro M, Dinh E, Wehrle C, Worley MJ, Doran N. A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men. Alcohol Clin Exp Res. 2017 Jan;41(1):197-206. doi: 10.1111/acer.13279. Epub 2016 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	200 mg	—

Indications