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Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double blind trial

P. Tønnesen, H. Lauri, R. Perfekt, K. Mann, A. Batra
European Respiratory Journal 2012; DOI: 10.1183/09031936.00155811
P. Tønnesen
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H. Lauri
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R. Perfekt
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K. Mann
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A. Batra
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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
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Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double blind trial
P. Tønnesen, H. Lauri, R. Perfekt, K. Mann, A. Batra
European Respiratory Journal Jan 2012, erj01558-2011; DOI: 10.1183/09031936.00155811

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Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double blind trial
P. Tønnesen, H. Lauri, R. Perfekt, K. Mann, A. Batra
European Respiratory Journal Jan 2012, erj01558-2011; DOI: 10.1183/09031936.00155811
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