Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial

Philip Tønnesen, Hans Lauri, Roland Perfekt, Karl Mann, Anil Batra, Philip Tønnesen, Hans Lauri, Roland Perfekt, Karl Mann, Anil Batra

Abstract

A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy, such as a faster uptake of nicotine and faster relief of craving. This multicentre, randomised (2:1), double-blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-verified continuous abstinence from smoking from week 2 until weeks 6, 24, and 52 in 479 smokers (≥ 1 cigarette per day) who were treated with either active (n=318) or placebo (n=161) spray for 12 weeks and low-intensity counselling at three smoking cessation clinics in Denmark and Germany. Active treatment yielded significantly higher continuous abstinence rates than placebo from week 2 until week 6 (26.1% versus 16.1%; relative success rate (RR) 1.62, 95% CI 1.09-2.41), week 24 (15.7% versus 6.8%; RR 2.30, 95% CI 1.23-4.30), and week 52 (13.8% versus 5.6%; RR 2.48, 95% CI 1.24-4.94). Most adverse events were mild to moderate, and 9.1% of subjects on active spray withdrew due to adverse events, compared to 7.5% on placebo. The overall rate of treatment-related adverse events was 87.4% with active spray versus 71.4% with placebo spray. Nicotine mouth spray delivered significantly higher 6-, 24- and 52-week continuous abstinence rates than placebo.

Trial registration: ClinicalTrials.gov NCT00759304 NCT00766584.

Conflict of interest statement

Statement of Interest

Statements of interest for all authors of this manuscript and for the study itself can be found at www.erj.ersjournals.com/site/misc/statements.xhtml

Figures

Figure 1–
Figure 1–
Flow diagram of the progress of subjects through the phases of the study.
Figure 2–
Figure 2–
Proportion of subjects with carbon monoxide-verified 7-day point prevalence of abstinence. Includes all subjects (nicotine mouth spray (NMS): n=318; placebo: n=161). *: p

Figure 3–

Median of the individual mean…

Figure 3–

Median of the individual mean daily number of spray doses by study week…

Figure 3–
Median of the individual mean daily number of spray doses by study week (weeks 1 to 12) in subjects in the nicotine mouth spray (NMS) group. Sprays/all: all NMS subjects reporting data for at least 50% of the days in that specific period; Sprays/abst: all NMS subjects with verified 7-day point prevalence abstinence reporting data for at least 50% of the days in that specific period.
Figure 3–
Figure 3–
Median of the individual mean daily number of spray doses by study week (weeks 1 to 12) in subjects in the nicotine mouth spray (NMS) group. Sprays/all: all NMS subjects reporting data for at least 50% of the days in that specific period; Sprays/abst: all NMS subjects with verified 7-day point prevalence abstinence reporting data for at least 50% of the days in that specific period.

References

    1. Stead LF, Perera R, Bullen C, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2008; 1: CD000146.
    1. Benowitz NL. Clinical pharmacology of nicotine: implications for understanding, preventing, and treating tobacco addiction. Clin Pharmacol Ther 2008; 83: 531–541
    1. Kraiczi H, Hansson A, Perfekt R. Single-dose pharmacokinetics of nicotine when given with a novel mouth spray for nicotine replacement therapy. Nicotine Tob Res 2011; 13: 1176–1182
    1. American PsychiatricAssociation(APA) Diagnostic and Statistical Manual of Mental Disorders 4th Edn Text Revision (DSM–IV-TR) Washington, APA, 2000
    1. Tønnesen P, Paoletti P, Gustavsson G, et al. Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Eur Respir J 1999; 13: 238–246
    1. Tønnesen P. Smoking cessation: how compelling is the evidence? A review. Health Policy 2009; 91: S15–S25
    1. Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, US Department of Health and Human Services, Public Health Service, 2008
    1. Goldstein MG, Niaura R, Follick MJ, et al. Effects of behavioral skills training and schedule of nicotine gum administration on smoking cessation. Am J Psychiatry 1989; 146: 56–60
    1. Killen JD, Fortmann SP, Newman B, et al. Evaluation of a treatment approach combining nicotine gum with self-guided behavioral treatments for smoking relapse prevention. J Consul Clin Psychol 1990; 58: 85–92
    1. Doherty K, Kinnunen T, Militello FS, et al. Urges to smoke during the first month of abstinence: relationship to relapse and predictors. Psychopharmacology 1995; 119: 171–178
    1. Killen JD, Fortmann SP. Craving is associated with smoking relapse: findings from three prospective studies. Exp Clin Psychopharmacol 1997; 5: 137–142
    1. West RJ, Hajek P, Belcher M. Severity of withdrawal symptoms as a predictor of outcome of an attempt to quit smoking. Psychol Med 1989; 19: 981–985
    1. Hays JT, Ebbert JO. Adverse effects and tolerability of medications for the treatment of tobacco use and dependence. Drugs 2010; 70: 2357–2372
    1. Ossip DJ, Abrams SM, Mahoney MC, et al. Adverse effects with use of nicotine replacement therapy among quitline clients. Nicotine Tob Res 2009; 11: 408–417
    1. Gonzales D, Rennard SI, Nides M, et al. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 2006; 296: 47–55
    1. Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA 2006; 296: 56–63
    1. Tonstad S, Tønnesen P, Hajek P, et al. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA 2006; 296: 64–71

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться