Objective: To determine the extent of side effects during the initial use of nicotine nasal spray for smoking cessation. Design: We performed a one-sample, noncomparative, open-label evaluation of the pattern of use, side effects, relief of withdrawal symptoms, and cotinine levels with nicotine nasal spray. Material and Methods: Adult smokers were recruited to use the nicotine nasal spray for smoking cessation at a dosage of 1 to 2 mg/h. Subjects completed daily diaries, which included an assessment of nicotine withdrawal symptoms, previously reported irritant effects of the nicotine nasal spray, and symptoms of nicotine toxicity. A plasma cotinine level was measured at baseline and at day 7 for calculation of percentage replacement. Results: The mean age of the 50 study subjects was 43.7 years, 46% were women, and the mean baseline smoking rate was 28.5 cigarettes per day. We found an increase in five symptoms (runny nose, nasal irritation, throat irritation, watering eyes, and sneezing) that had been essentially absent before initiation of use of the nicotine nasal spray. All but throat irritation decreased significantly during days 0 through 7 of the study. The mean daily frequency of nicotine nasal spray use for the first week was 15.0 doses. Use of the nasal spray decreased significantly (P<0.001) during the initial 8 weeks of treatment. The mean percentage cotinine replacement for those subjects who were abstinent at day 7 was 38.6%. Conclusion: Although nicotine nasal spray causes substantial irritant side effects during the first few days of use, these adverse effects decrease significantly within the first week. Despite these side effects, subjects continued to use the nicotine nasal spray and experienced a high rate of initial abstinence from smoking.
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