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CME Released: 7/25/2005
Valid for credit through: 7/25/2006
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July 26, 2005 -- Topiramate is safe and effective for smoking cessation in alcohol-dependent patients, according to the results of a subgroup analysis of a randomized trial reported in the July 25 issue of the Archives of Internal Medicine.
"Despite the proposal that smoking cessation can trigger alcohol relapse among the dually dependent, contemporary studies show that smoking cessation treatment does not cause abstinent alcoholics to relapse and could reduce moderate to heavy drinking among those still consuming alcohol," write Bankole A. Johnson, DSc, MD, PhD, from the University of Virginia in Charlottesville, and colleagues. "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."
This subgroup analysis was part of a larger, double-blind, 12-week study comparing topiramate and placebo as treatment for alcohol dependence. Of 94 cigarette-smoking, alcohol-dependent individuals, 45 were randomized to receive topiramate at an escalating dose from 25 to 300 mg per day, and 49 received placebo in addition to weekly standardized medication compliance management. The main outcome was smoking cessation based on self-report and confirmed by the level of serum cotinine, the major metabolite of nicotine.
Compared with patients receiving placebo, those receiving topiramate were at least four times more likely to abstain from smoking (odds ratio [OR], 4.46; 95% confidence interval [CI], 1.08 - 18.39; P = .04). When a serum cotinine level of 28 ng/mL or lower was used to separate nonsmokers from smokers, patients receiving topiramate were nearly five times as likely to be nonsmokers (OR, 4.97; 95% CI, 1.1 - 23.4; P = .04). For topiramate recipients, smoking cessation rates were 19.4% at week 9 and 16.7% at week 12, vs 6.9% at both time points for placebo recipients.
Study limitations include post hoc analysis of smoking behavior, inclusion only of cigarette smokers, lack of follow-up, exclusion of patients with comorbid axis 1 psychiatric disorders, relatively small sample size, and short study duration.
"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," the authors write. "This finding should garner scientific interest because no medication has been established as an effective treatment for comorbid alcohol and nicotine dependence."
Ortho-McNeil Pharmaceutical Inc., maker of Topamax, provided medication and a research grant in partial support of this project, which was also supported by the University of Texas Health Science Center at San Antonio and the National Institute on Alcohol Abuse and Alcoholism.
Arch Intern Med. 2005;165:1600-1605
