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Published online September 1, 2008
PEDIATRICS Vol. 122 No. 3 September 2008, pp. e595-e600 (doi:10.1542/peds.2008-0501)
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ARTICLE

A Randomized Trial of Nicotine Nasal Spray in Adolescent Smokers

Mark L. Rubinstein, MDa, Neal L. Benowitz, MDb, Glenna M. Auerback, MPHa, Anna-Barbara Moscicki, MDa

Division of a Adolescent Medicine, Department of Pediatrics
b Division of Clinical Pharmacology and Experimental Therapeutics, Departments of Medicine, Psychiatry, and Biopharmaceutical Sciences, University of California, San Francisco, California

OBJECTIVES. Nicotine nasal spray has been 1 of the most successful forms of nicotine-replacement therapy in adult populations. The nasal sprayer has not been studied in adolescent smokers. The objective of this pilot study was to determine the feasibility and utility of using nicotine nasal spray for adolescent smokers who wanted to quit smoking.

METHODS. Forty adolescent smokers who were between 15 and 18 years of age and smoked ≥5 cigarettes daily for at least 6 months were recruited from several San Francisco Bay area schools from 2005 to 2007. Using a randomized, open-label, 12-week trial, adolescent smokers were assigned to receive either weekly counseling alone (control) for 8 weeks or 8 weeks of counseling along with 6 weeks of nicotine nasal spray. Self-reported smoking abstinence was verified by both expired-air carbon monoxide and salivary cotinine.

RESULTS. There was no difference in cessation rates, the numbers of cigarettes smoked per day, or cotinine levels at 12 weeks. Fifty-seven percent of participants stopped using their spray after only 1 week. The most commonly reported adverse effect was nasal irritation and burning (34.8%) followed by complaints about the taste and smell (13%).

CONCLUSIONS. The unpleasant adverse effects, poor adherence, and consequent lack of efficacy observed in our pilot study do not support the use of nicotine nasal spray as an adjunct to counseling for adolescent smokers who wish to quit.

Key Words: smoking cessation • adolescent • nicotine nasal spray

Abbreviations: NRT—nicotine-replacement therapy • NNS—nicotine nasal spray • cpd—cigarettes per day • CO—expired-air carbon monoxide

Accepted May 14, 2008.


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