A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy.
BACKGROUND
Various formulations of nicotine replacement therapy are commercially available.


OBJECTIVE
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.
Bolliger
C T
CT
Respiratory Research Unit, Faculty of Health Sciences, University of Stellenbosch, Cape Town, South Africa. ctb@sun.ac.za
van Biljon
X
X
Axelsson
A
A
D000280:Administration, Inhalation; D000287:Administration, Topical; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009055:Mouth; D009538:Nicotine / Q000008:administration & dosage*; D018722:Nicotinic Agonists / Q000008:administration & dosage*; D010865:Pilot Projects; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome
D018722:Nicotinic Agonists; D009538:Nicotine