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 (≥1 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% versus 16.1%; relative success rate (RR) 1.62, 95% CI 1.09–2.41), week 24 (15.7% versus 6.8%; RR 2.30, 95% CI 1.23–4.30), and week 52 (13.8% versus 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 spray versus 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
Footnotes
Clinical Trial
This study is registered at Clinicaltrials.gov with clinical trial identifier numbers NCT00759304 and NCT00766584.
Statement of Interest
Statements of interest for all authors of this manuscript and for the study itself can be found at www.erj.ersjournals.com/site/misc/statements.xhtml
This article was modified in April 2016 to correct errors in the licence information.
- Received September 8, 2011.
- Accepted January 11, 2012.
- ©ERS 2012
ERJ Open articles are open access and distributed under the terms of the (Creative Commons Attribution Non-Commercial Licence 3.0)