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 receivedindividualized 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 (n = 100) and placebo (n = 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.
RCT Entities:
OBJECTIVE: To estimate the safety and efficacy of treatment with 2-mg nicotinegum 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 nicotinegum 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 (n = 100) and placebo (n = 94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotinegum 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, nicotinegum significantly reduced the number of cigarettes smoked per day (nicotinegum: -5.7 [standard deviation (SD)=6.0]; placebo: -3.5 [SD=5.7], P=.035), and cotinine concentration (nicotinegum: -249 ng/mL [SD=397]; placebo: -112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotinegum 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 nicotinegum did not increase quit rates, use of nicotinegum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing.
Authors: Kathryn I Pollak; Cheryl A Oncken; Isaac M Lipkus; Pauline Lyna; Geeta K Swamy; Pamela K Pletsch; Bercedis L Peterson; R Phillips Heine; Rebecca J Namenek Brouwer; Laura Fish; Evan R Myers Journal: Am J Prev Med Date: 2007-10 Impact factor: 5.043
Authors: Cheryl Oncken; Richard Feinn; Jonathan Covault; Valerie Duffy; Ellen Dornelas; Henry R Kranzler; Heather Z Sankey Journal: Nicotine Tob Res Date: 2015-04-01 Impact factor: 4.244
Authors: Jennifer Gilbert; Robert Schnoll; Mary F Morrison; Sindhu K Srinivas; Timothy Pond; Brenda Curtis; Jennifer Henry; Henry R Kranzler Journal: Addict Disord Their Treat Date: 2014-05-29
Authors: Marian P Jarlenski; Margaret S Chisolm; Sarah Kachur; Donna M Neale; Wendy L Bennett Journal: Am J Prev Med Date: 2015-05 Impact factor: 5.043
Authors: Angela L Stotts; Thomas F Northrup; Paul M Cinciripini; Jennifer A Minnix; Janice A Blalock; Patricia Dolan Mullen; Claudia Pedroza; Sean Blackwell Journal: Am J Perinatol Date: 2014-08-11 Impact factor: 1.862
Authors: Kevin M Walton; David B Abrams; William C Bailey; David Clark; Gregory N Connolly; Mirjana V Djordjevic; Thomas E Eissenberg; Michael C Fiore; Maciej L Goniewicz; Lynne Haverkos; Stephen S Hecht; Jack E Henningfield; John R Hughes; Cheryl A Oncken; Lisa Postow; Jed E Rose; Kay L Wanke; Lucie Yang; Dorothy K Hatsukami Journal: Nicotine Tob Res Date: 2014-10-21 Impact factor: 4.244