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.




Smoking Prevalence In Early Pregnancy: Comparison Of Self-report And Anonymous Urine Cotinine Testing
Authors: Swamy G.K. , Reddick K.L. , Brouwer R.J. , Pollak K.I. , Myers E.R. .
Source: The Journal Of Maternal-fetal & Neonatal Medicine : The Official Journal Of The European Association Of Perinatal Medicine, The Federation Of Asia And Oceania Perinatal Societies, The International Society Of Perinatal Obstetricians, 2011 Jan; 24(1), p. 86-90.
PMID: 20384470
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What Do We Know About The Role Of Pharmacotherapy For Smoking Cessation Before Or During Pregnancy?
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Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2009 Nov; 11(11), p. 1265-73.
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Predictors Of Adverse Events Among Pregnant Smokers Exposed In A Nicotine Replacement Therapy Trial
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Source: American Journal Of Obstetrics And Gynecology, 2009 Oct; 201(4), p. 354.e1-7.
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Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2009 May; 11(5), p. 514-8.
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Olfactory And Gustatory Sensory Changes To Tobacco Smoke In Pregnant Smokers
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Source: Research In Nursing & Health, 2008 Feb; 31(1), p. 31-41.
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Empathy Goes A Long Way In Weight Loss Discussions
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Source: The Journal Of Family Practice, 2007 Dec; 56(12), p. 1031-6.
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Nicotine Replacement And Behavioral Therapy For Smoking Cessation In Pregnancy
Authors: Pollak K.I. , Oncken C.A. , Lipkus I.M. , Lyna P. , Swamy G.K. , Pletsch P.K. , Peterson B.L. , Heine R.P. , Brouwer R.J. , Fish L. , et al. .
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Rated Helpfulness And Partner-reported Smoking Cessation Support Across The Pregnancy-postpartum Continuum
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Source: Health Psychology : Official Journal Of The Division Of Health Psychology, American Psychological Association, 2006 Nov; 25(6), p. 762-70.
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Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial.
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