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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