title: A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy.
abstract: 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.
authors.affiliation: Respiratory Research Unit, Faculty of Health Sciences, University of Stellenbosch, Cape Town, South Africa. ctb@sun.ac.za
authors.forename: C T
authors.initials: CT
authors.lastname: Bolliger
authors.forename: X
authors.initials: X
authors.lastname: van Biljon
authors.forename: A
authors.initials: A
authors.lastname: Axelsson
mesh_terms: 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
chemical_list: D018722:Nicotinic Agonists; D009538:Nicotine