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Randomized Controlled Trial
. 2009 Sep;22(9):751-8.
doi: 10.3109/14767050902994515.

Effects of nicotine patch or nasal spray on nicotine and cotinine concentrations in pregnant smokers

Affiliations
Randomized Controlled Trial

Effects of nicotine patch or nasal spray on nicotine and cotinine concentrations in pregnant smokers

Cheryl Oncken et al. J Matern Fetal Neonatal Med. 2009 Sep.

Abstract

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 (p = 0.002). Percent change in cotinine concentration differed across groups (reduction = 77% with placebo, 70% with nasal spray, and 48% with patch; p = 0.029). Maternal heart rate decreased in the placebo and nasal spray groups compared with the patch group (p = 0.021). 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 (p = 0.052). Daily, cigarette craving decreased more in the patch versus the other groups (p = 0.025).

Conclusions: Nicotine patch and nasal spray reduce maternal nicotine exposure compared with smoking and may be effective for smoking cessation.

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Figures

Figure 1a and b
Figure 1a and b
Mean craving scores and total withdrawal scores while smoking (screening) and while using nicotine patch, nicotine nasal spray, or placebo for smoking cessation.
Figure 1a and b
Figure 1a and b
Mean craving scores and total withdrawal scores while smoking (screening) and while using nicotine patch, nicotine nasal spray, or placebo for smoking cessation.
Figure 2
Figure 2
Nicotine concentrations while smoking (N=21) and after four days of nicotine patch, or nasal spray or placebo use. While smoking, nicotine concentrations were obtained after overnight abstinence (Trough 1), 2 minutes after completion of the first and fourth cigarettes of the day (Peak 1 and 2) and immediately before and 2 minutes after the 7th cigarette of the day (Trough 2 and Peak 3). The patch was placed at 10 am and nicotine levels were obtained at the abovenamed times. Eleven doses of nasal spray were administered during the session (at 9:55 am, 10 am, 10:40 am, 11am, 12:05 and 12:10 am, 1:30pm. 2:00pm, 3:20 and 3:25, 4:20).

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