A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy

Respiration. 2007;74(2):196-201. doi: 10.1159/000097136. Epub 2006 Nov 14.

Abstract

Background: Various formulations of nicotine replacement therapy are commercially available.

Objectives: It was the aim of this study to test preference, safety and efficacy of a new nicotine mouth spray (1 mg/actuation; NicoNovum).

Methods: One hundred healthy smokers wanting to quit (mean age 43.1 +/- 11.2 years) were included. They were given the mouth spray, as well as 2-mg nicotine gums and nicotine oral inhalers to try out for 1 week. Subsequently, all participants were randomized into 3 groups - mouth spray (n = 50), gum (n = 25) and inhaler (n = 25) - and treated for 3 months.

Results: Fifty-four of the hundred smokers preferred the spray, compared with 28 and 18 who preferred the gum and inhaler, respectively (p < 0.01 for spray vs. both the gum and inhaler). At 6 months, the sustained abstinence rates were 8 (16%), 5 (20%) and 2 (8%) for the mouth spray, gum and inhaler, respectively (p values = n.s.). Adverse effects (AEs) were mostly drug-related local symptoms, most frequently reported at the end of the tryout period: out of 106 drug-related AEs, 90 were due to the spray, 11 and 5 to the inhaler and gum, respectively. The three most frequent AEs were almost exclusively caused by the spray: burning of the tongue/throat reported by 35, nausea by 18, and hiccup by 16 participants.

Conclusions: Participants preferred the mouth spray over the gum and inhaler, but its use was coupled with a high rate of local AEs. The efficacy of the mouth spray seemed comparable with the one obtained by the gum and inhaler. Further studies are necessary to show whether a reduction in the dose per actuation to about 0.5 mg would result in less side effects, which in turn might yield higher long-term drug compliance and possibly higher success rates than the ones achieved with other forms of nicotine replacement therapy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Administration, Topical
  • Adult
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Mouth
  • Nicotine / administration & dosage*
  • Nicotinic Agonists / administration & dosage*
  • Pilot Projects
  • Smoking Cessation / methods*
  • Treatment Outcome

Substances

  • Nicotinic Agonists
  • Nicotine