Use of oral topiramate to promote smoking abstinence among alcohol-dependent smokers: a randomized controlled trial.
BACKGROUND
Previously, our group has shown that topiramate, a sulfamate-substituted fructopyranose derivative, is an effective treatment for alcohol dependence. Herein, we extend that proof-of-concept study by determining whether cigarette-smoking, alcohol-dependent individuals from the earlier study also experienced improved smoking outcomes.


METHODS
As a subgroup analysis of a larger double-blind, randomized, controlled, 12-week study comparing topiramate vs placebo as treatment for alcohol dependence, a 12-week clinical trial compared topiramate vs placebo in 94 cigarette-smoking, alcohol-dependent individuals. Of these, 45 were assigned to receive topiramate (escalating dose from 25 to 300 mg/d) and the remaining 49 had placebo as an adjunct to weekly standardized medication compliance management. The primary outcome was smoking cessation ascertained by self-report and confirmed by the level of serum cotinine (nicotine's major metabolite).


RESULTS
Topiramate recipients were significantly more likely than placebo recipients to abstain from smoking (odds ratio, 4.46; 95% confidence interval, 1.08-18.39; P = .04). Using a serum cotinine level of 28 ng/mL or lower to segregate nonsmokers from smokers, we found that the topiramate group had 4.97 times the odds of being nonsmokers (95% confidence interval, 1.1-23.4;P = .04). Smoking cessation rates for topiramate recipients were 19.4% and 16.7% at weeks 9 and 12, respectively, compared with 6.9% at both time points for placebo recipients.


CONCLUSIONS
In this trial, topiramate (up to 300 mg/d) showed potential as a safe and promising medication for the treatment of cigarette smoking in alcohol-dependent individuals.
Johnson
Bankole A
BA
Department of Psychiatric Medicine, University of Virginia, Charlottesville 22908-0623, USA. bankolejohnson@virginia.edu
Ait-Daoud
Nassima
N
Akhtar
Fatema Z
FZ
Javors
Martin A
MA
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000437:Alcoholism / Q000097:blood / Q000150:complications*; D000927:Anticonvulsants / Q000008:administration & dosage; D003367:Cotinine / Q000097:blood; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005632:Fructose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012907:Smoking / Q000097:blood / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*; D000077236:Topiramate; D016896:Treatment Outcome
D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose; D003367:Cotinine