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

dc.contributor.authorBolliger C.T.
dc.contributor.authorVan Biljon X.
dc.contributor.authorAxelsson A.
dc.date.accessioned2011-05-15T15:57:32Z
dc.date.available2011-05-15T15:57:32Z
dc.date.issued2007
dc.identifier.citationRespiration
dc.identifier.citation74
dc.identifier.citation2
dc.identifier.issn257931
dc.identifier.other10.1159/000097136
dc.identifier.urihttp://hdl.handle.net/10019.1/10453
dc.description.abstractBackground: 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. Copyright © 2006 S. Karger AG.
dc.subjectniconovum
dc.subjectnicotine
dc.subjectunclassified drug
dc.subjectadult
dc.subjectaerosol
dc.subjectarticle
dc.subjectchewing gum
dc.subjectcontrolled study
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectfemale
dc.subjecthiccup
dc.subjecthuman
dc.subjecthuman experiment
dc.subjectinhaler
dc.subjectmale
dc.subjectnausea
dc.subjectnormal human
dc.subjectpilot study
dc.subjectpriority journal
dc.subjectrecommended drug dose
dc.subjectsmoking cessation
dc.subjectthroat burning sensation
dc.subjecttongue burning sensation
dc.subjectAdministration, Inhalation
dc.subjectAdministration, Topical
dc.subjectAdult
dc.subjectFemale
dc.subjectFollow-Up Studies
dc.subjectHumans
dc.subjectMale
dc.subjectMouth
dc.subjectNicotine
dc.subjectNicotinic Agonists
dc.subjectPilot Projects
dc.subjectSmoking Cessation
dc.subjectTreatment Outcome
dc.titleA nicotine mouth spray for smoking cessation: A pilot study of preference, safety and efficacy
dc.typeArticle
dc.description.versionArticle


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