Nicotine replacement and behavioral therapy for smoking cessation in pregnancy

Abstract

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

Methods: 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.

Results: 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 time points (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 higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth.

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

Trial registration: ClinicalTrials.gov NCT00224419.

Figure 1. Flow of participants through the study

“Active refusal” indicates potential participants who were contacted but declined to participate. “Passive refusal” indicates potential participants with whom contact was not possible. Once randomized, self-reported smoking status was assessed by telephone interview 7 weeks after randomization, at 38-weeks gestational age, and at 3-months postpartum. At each timepoint, “delivered” indicates participants who delivered prior to the time of assessment; “unable to contact within window” indicates participants who were not reachable by phone within the 3-week window allowed for contact; “withdrew” indicates participants who refused further participation in surveys; “declined survey” indicates participants who declined to respond to the phone interview at that point in time but indicated willingness to be contacted in the future; and “withdrew” indicates participants who both refused to participate and did not wish to be contacted at future timepoints.