Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.
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.
Pollak
Kathryn I
KI
Cancer Prevention, Detection and Control Research Program, Comprehensive Cancer Center, Duke University Medical Center, 2424 Erwin Road, Durham, NC 27705, USA. kathryn.pollak@duke.edu
Oncken
Cheryl A
CA
Lipkus
Isaac M
IM
Lyna
Pauline
P
Swamy
Geeta K
GK
Pletsch
Pamela K
PK
Peterson
Bercedis L
BL
Heine
R Phillips
RP
Brouwer
Rebecca J Namenek
RJ
Fish
Laura
L
Myers
Evan R
ER
D000328:Adult; D001521:Behavior Therapy; D005260:Female; D006801:Humans; D009538:Nicotine / Q000627:therapeutic use; D018722:Nicotinic Agonists / Q000627:therapeutic use; D009657:North Carolina; D011247:Pregnancy; D016540:Smoking Cessation / Q000379:methods / Q000523:psychology*; D014029:Tobacco Use Disorder / Q000188:drug therapy*
D018722:Nicotinic Agonists; D009538:Nicotine