Document Type



Medicine and Health Sciences




This study examines whether adding nicotine replacement therapy (NRT) to cognitive behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation.


An open-label randomized trial (Baby Steps, n = 181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7-weeks post-randomization, 38-weeks gestation, and 3-months postpartum.


Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy timepoints (after 7 weeks: 24% vs 8%, p = 0.02; at 38-weeks gestation: 18% vs 7%, p =0.04), but not at 3-months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an independent Data and Safety Monitoring Board when an interim analysis found a greater rate of negative birth outcomes in the CBT+NRT arm than in the CBT arm. At the final analysis the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), adjusted for prior history of preterm birth.


The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine the safety and to confirm the efficacy of NRT use during pregnancy.


Am J Prev Med. Author manuscript; available in PMC 2013 March 20. Published in final edited form as: Am J Prev Med. 2007 October; 33(4): 297–305. doi: 10.1016/j.amepre.2007.05.006 PMCID: PMC3602964 NIHMSID: NIHMS31580