Objective.To examine the short-term effects of the nicotine patch or nasal spray on measures of nicotine exposure, withdrawal symptoms, and on maternal and fetal heart rates in pregnant smokers. Methods.We measured nicotine/cotinine concentrations and maternal and fetal heart rates during an 8-h monitoring session while smoking and again after 4 days of nicotine patch (15 mg/16 h), nasal spray (recommended regimen of 24 doses per day), or placebo treatment. Nicotine withdrawal symptoms were assessed daily. Results.Twenty-one subjects, who smoked an average of 17 cigarettes per day, completed both monitoring sessions. Nicotine concentrations decreased from baseline smoking concentrations in all groups (p0.002). Percent change in cotinine concentration differed across groups (reduction77 with placebo, 70 with nasal spray, and 48 with patch; p0.029). Maternal heart rate decreased in the placebo and nasal spray groups compared with the patch group (p0.021). The baseline fetal heart rate decreased in the placebo group throughout the second monitoring session, but increased slightly in the patch and nasal spray groups. The treatment by time interaction was marginally significant (p0.052). Daily, cigarette craving decreased more in the patch versus the other groups (p0.025). Conclusions.Nicotine patch and nasal spray reduce maternal nicotine exposure compared with smoking and may be effective for smoking cessation.
Bibliographical noteFunding Information:
Supported by NIH grants R01 DA15167, K24 AA13736, and M01 RR06192 (University of Connecticut General Clinical Research Center). Pharmacia and Upjohn Consumer Healthcare (Helsingborg, Sweden) donated nicotine and placebo patches and nasal spray. Dr. Oncken has received consulting fees and honoraria from Pfizer (New York, NY). She has received at no cost nicotine and/or placebo products from Glaxo-SmithKline (Philadelphia, PA) for smoking cessation studies. She has received grant funding from Pfizer and from Nabi Biopharmaceuticals (Boca Raton, FL). Dr. Kranzler has received research support from Ortho-McNeil Pharmaceuticals and Bristol-Myers Squibb Co. He has received consulting fees from Ortho-McNeil Pharmaceuticals, H. Lundbeck A/S, Forest Pharmaceuticals, elbion NV, Sanofi-Aventis, Solvay Pharmaceuticals, and Alkermes, Inc. He has received honoraria from Forest Pharmaceuticals and Alkermes, Inc.