What is the best way to help someone quit smoking? A recent trial compared the most popular over-the- counter and prescription treatments to answer this question. 1,504 participants were randomly assigned to one of six conditions: a nicotine patch, a nicotine lozenge, a patch + lozenge, bupropion, bupropion + lozenge, or placebo. In addi- tion, all participants had six 10 to 20 minute counseling sessions with a supervised bachelor’s-level clinician.The lozenge was taken for 12 weeks, while other treatments were given for eight weeks.The main outcome variable was the seven day abstinence rate, as confirmed by expired carbon monoxide levels during study visits.After eight weeks, three of the treatments were statistically significantly more effective than placebo (which yielded a 30.2% abstinence rate): the patch alone (44.7%), the patch + lozenge (53.6%), and bupro- pion + lozenge (50.4%).At six months post quit (four months after treatment was discontinued), only patch + lozenge was more effective than placebo (40.1% vs. 22.2%). All the treatments were well- tolerated; only four participants withdrew due to medication-related adverse events (Piper ME et al., Arch Gen Psychiatry 2009;66:1253–1262).

TCPR’s Take: While these results may seem discouraging, the authors used a conservative statistical approach to adjust for multiple comparisons.When they reanalyzed the results using a more liberal technique, they found that all five treatments led to higher quit rates than placebo. Nonetheless, the take-home mes- sage from this and other clinical trials is that combining the patch with some form of ad-lib nicotine replacement (such as the nicotine lozenge, gum, or spray) is particularly effective. Unfortunately, Chantix (varenicline) was nottested in this study because it had not yet been approved by the FDA.A recent open-label randomized trial found Chantix more effective than the nicotine patch alone (without ad-lib nicotine replacement), with Chantix yielding a 55.9% abstinence rate after 12 weeks vs. 43.2% for the patch (Aubin HJ, et al., Thorax 2008;63:717–24). However, the patch was used alone without ad-lib nicotine replacement, and the Chantix advantage was no longer significant after one year.