Nicotine Gum for Pregnant Smokers: A Randomized Controlled Trial

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OBJECTIVE:To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy.METHODS:Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study.RESULTS:Participants in the nicotine (nequals;100) and placebo (nequals;94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32–34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: −5.7 [standard deviation (SD)=6.0]; placebo: −3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: −249 ng/mL [SD=397]; placebo: −112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014).CONCLUSION:Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing.CLINICAL TRIAL,, NCT00115687LEVEL OF EVIDENCE:I

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