Combination of Nicotine Patch Plus Lozenges Produces Greatest Smoking Cessation Benefit in Randomized Controlled Trial
Page Tools
In a head-to-head comparison of five smoking cessation pharmacotherapies, combination therapy with a nicotine patch plus nicotine lozenges was found to provide the greatest benefit relative to placebo. The results of the randomized, double-blind, placebo-controlled trial appear in the November 2009 issue of the Archives of General Psychiatry.
The trial included 1,504 adults in Wisconsin who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit. Participants were randomized to one of six study arms:
• Nicotine lozenge for 12 weeks postquit
• Nicotine patch titrated down during 8 weeks postquit
• Sustained-release bupropion 150 mg twice daily for 1 week prequit and 8 weeks postquit
• Nicotine patch plus nicotine lozenge
• Bupropion plus nicotine lozenge
• Placebo (five types, matched to each of the active treatments).
In addition, all participants received more than 60 minutes of counseling provided as six individual sessions. The main study outcome was biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit. Other outcomes included initial cessation, number of days to lapse, and number of days to relapse.
With the exception of the nicotine lozenge at 1 week after the quit date, all of the active treatments produced higher rates of initial cessation and higher 7-day point-prevalence abstinence rates at 1 week, end of treatment, and 6 months postquit, relative to placebo. However, the odds ratio (OR) for patch plus lozenge at 6 months postquit was 2.34, while the next highest OR was 1.83 (for the nicotine patch). When the results were corrected to account for multiple comparisons, only combination therapy with the patch plus lozenge was efficacious at 6 months post-quit.
Arch Gen Psychiatry. 2009;66(11):1253-62.