Abstract
A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy such as a faster uptake of nicotine and faster relief of craving.
This multicentre, randomised (2:1), double blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-verified continuous abstinence from smoking from Week 2 until Weeks 6, 24, and 52 in 479 smokers (≥ one cigarette per day) who were treated with either active (n=318) or placebo (n=161) spray for 12 weeks and low-intensity counselling at three smoking cessation clinics in Denmark and Germany.
Active treatment yielded significantly higher continuous abstinence rates than placebo from Week 2 until Week 6 (26.1% vs. 16.1%, relative success rate (RR) 1.62, 95% confidence interval (CI), 1.09, 2.41), Week 24 (15.7% vs. 6.8%, RR 2.30, 95%CI, 1.23, 4.30), and Week 52 (13.8% vs. 5.6%, RR 2.48, 95% CI, 1.24, 4.94). Most adverse events were mild to moderate, and 9.1% of subjects on active spray withdrew due to adverse events, compared to 7.5% on placebo. The overall rate of treatment-related adverse events was 87.4% with active vs. 71.4% with placebo spray.
Nicotine mouth spray delivered significantly higher 6-, 24-, and 52-Week continuous abstinence rates than placebo.
- Continuous abstinence
- intention-to-treat
- low-intensity counselling
- nicotine replacement therapy
- placebo-controlled
- ERS
