Grant Details
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 |
Abstract
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.
Publications
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.
EPub date: 2010-04-12.
PMID: 20384470
Related Citations
What do we know about the role of pharmacotherapy for smoking cessation before or during pregnancy?
Authors: Oncken C.A.
, Kranzler H.R.
.
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2009 Nov; 11(11), p. 1265-73.
EPub date: 2009-08-28.
PMID: 19717542
Related Citations
Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial.
Authors: Swamy G.K.
, Roelands J.J.
, Peterson B.L.
, Fish L.J.
, Oncken C.A.
, Pletsch P.K.
, Myers E.R.
, Whitecar P.W.
, Pollak K.I.
.
Source: American journal of obstetrics and gynecology, 2009 Oct; 201(4), p. 354.e1-7.
EPub date: 2009-08-07.
PMID: 19664750
Related Citations
Adherence to nicotine replacement therapy among pregnant smokers.
Authors: Fish L.J.
, Peterson B.L.
, Namenek Brouwer R.J.
, Lyna P.
, Oncken C.A.
, Swamy G.K.
, Myers E.R.
, Pletsch P.K.
, Pollak K.I.
.
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2009 May; 11(5), p. 514-8.
EPub date: 2009-04-07.
PMID: 19351783
Related Citations
Olfactory and gustatory sensory changes to tobacco smoke in pregnant smokers.
Authors: Pletsch P.K.
, Pollak K.I.
, Peterson B.L.
, Park J.
, Oncken C.A.
, Swamy G.K.
, Lyna P.
.
Source: Research in nursing & health, 2008 Feb; 31(1), p. 31-41.
PMID: 18161772
Related Citations
Empathy goes a long way in weight loss discussions.
Authors: Pollak K.I.
, Østbye T.
, Alexander S.C.
, Gradison M.
, Bastian L.A.
, Brouwer R.J.
, Lyna P.
.
Source: The Journal of family practice, 2007 Dec; 56(12), p. 1031-6.
PMID: 18053443
Related Citations
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.
.
Source: American journal of preventive medicine, 2007 Oct; 33(4), p. 297-305.
PMID: 17888856
Related Citations
Rated helpfulness and partner-reported smoking cessation support across the pregnancy-postpartum continuum.
Authors: Pollak K.I.
, Baucom D.H.
, Peterson B.L.
, Stanton S.
, McBride C.M.
.
Source: Health psychology : official journal of the Division of Health Psychology, American Psychological Association, 2006 Nov; 25(6), p. 762-70.
PMID: 17100504
Related Citations
Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial.
Authors: Pollak K.I.
, Oncken C.A.
, Lipkus I.M.
, Peterson B.L.
, Swamy G.K.
, Pletsch P.K.
, Lyna P.
, Namenek Brouwer R.J.
, Fish L.J.
, Myers E.R.
.
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2006 Aug; 8(4), p. 547-54.
PMID: 16920652
Related Citations
Knowledge and perceived risk of smoking-related conditions: a survey of cigarette smokers.
Authors: Oncken C.
, McKee S.
, Krishnan-Sarin S.
, O'Malley S.
, Mazure C.M.
.
Source: Preventive medicine, 2005 Jun; 40(6), p. 779-84.
PMID: 15850879
Related Citations
Gender effects of reported in utero tobacco exposure on smoking initiation, progression and nicotine dependence in adult offspring.
Authors: Oncken C.
, McKee S.
, Krishnan-Sarin S.
, O'Malley S.
, Mazure C.
.
Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2004 Oct; 6(5), p. 829-33.
PMID: 15700918
Related Citations
Pharmacotherapies to enhance smoking cessation during pregnancy.
Authors: Oncken C.A.
, Kranzler H.R.
.
Source: Drug and alcohol review, 2003 Jun; 22(2), p. 191-202.
PMID: 12850906
Related Citations
Effect of maternal smoking on fetal catecholamine concentrations at birth.
Authors: Oncken C.A.
, Henry K.M.
, Campbell W.A.
, Kuhn C.M.
, Slotkin T.A.
, Kranzler H.R.
.
Source: Pediatric research, 2003 Jan; 53(1), p. 119-24.
PMID: 12508090
Related Citations