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  • Title: A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy.
    Author: Bolliger CT, van Biljon X, Axelsson A.
    Journal: Respiration; 2007; 74(2):196-201. PubMed ID: 17108670.
    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.
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