Snus as a smoking cessation aid: a randomized placebo-controlled trial.

INTRODUCTION

Snus is a low-nitrosamine smokeless product that appears to be safer than other smokeless products. Evidence indicates that snus has been used as an effective smoking cessation aid in Scandinavia. No randomized controlled trial has directly tested the efficacy of snus for smoking cessation.

METHODS

This randomized, double-blind, placebo-controlled multicentre trial tested the efficacy of snus for smoking cessation. Of the 250 subjects, 125 were randomized to active or placebo snus sachets. Subjects were followed up through 28 weeks after randomization. In total, 5 clinical visits and 8 telephone contacts were scheduled. Primary outcome measure was biologically verified continuous smoking abstinence from Week 6 through 28.

RESULTS

The continuous abstinence rate during Weeks 6-28 in the snus and placebo groups was 4.0% and 1.6% (odds ratio [OR]: 2.5, 95% CI: 0.4-27), respectively. The point prevalence abstinence rate at 6 weeks was 18.4% in the snus group versus 8.8% in the placebo group (OR: 2.3, 95% CI: 1.1-5.0, p = .03). At Week 28, the difference in favor of the snus group was not statistically significant (12.8% vs. 7.2%, OR: 1.9, 95% CI: 0.8-4.4). Snus was generally well tolerated. Treatment-related adverse events that were more common in the snus group were generally mild and included nausea, dyspepsia, gingivitis, hiccups, and dizziness.

CONCLUSIONS

Although the cessation rates generally were low and, at 28 weeks, did not differ between active and placebo, early quit rates suggested that snus was superior and with similar effect sizes to those with nicotine replacement. These results suggest that snus needs to be further researched as a smoking cessation treatment.