Grant Number:	5R01CA089053-05 Interpret this number
Primary Investigator:	Pollak, Kathryn
Organization:	Duke University
Project Title:	Testing Pharmacological Therapies for Pregnant Smokers
Fiscal Year:	2006

DESCRIPTION (provided by investigator): Smoking in pregnancy poses serious health risks to the fetus and the mother. About half of women smokers continue to smoke throughout pregnancy. Pregnant women who have the greatest difficulty quitting smoking even when provided with behavioral cessation interventions tend to be more dependent smokers who may requite nicotine replacement therapy to be successful at cessation. The proposed five-year study is designed to evaluate the effectiveness of providing over-the-counter (OTC) nicotine replacement therapy, choice of gum or patch, (NRT) to promote prepartum smoking cessation. Proposed is a two-arm design. Eligible pregnant women (N=300) will be randomized to either: Arm 1, Tailored Cognitive Behavioral Treatment (TCBT, n=150) that provides women with customized risk information about smoking and nicotine, the potential harms to the fetus and encouragement of appropriate behavioral skills building; or Arm 2, TCBT + NRT - the tailored intervention incorporating NRT information plus choice of patch or gum (n about150). The intervention will include 5 face-to-face contacts as part of prenatal visits and 2 telephone counseling sessions. Primary outcome measures will be biochemically validated 7-day prevalent abstinence rates at the 19-27th and 27-35th week of pregnancy. Secondary outcomes will include 7-day prevalent abstinence rates at 12 and 24 weeks postpartum, serious quit attempts, compliance with NRT, and use of materials. Saliva cotinine will be measured among all women at baseline, the 27-35th week of pregnancy, and 24 weeks postpartum. The significance of this project is that it relies on transdisciplinary collaborations to extend the science in nicotine replacement therapies to a population that could derive substantial health benefits. Moreover, the study results have immediate potential to inform clinical recommendations for integrating nicotine replacement into prenatal care.





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