Trial Information

Testing Pharmacological Therapies for Pregnant Smokers

The proposed five-year study is designed to evaluate the effectiveness of providing
over-the-counter (OTC) nicotine replacement therapy, choice of gum, lozenge 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=100) 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=200). The intervention will include 5
face-to-face contacts as part of prenatal visits and 1 telephone counseling session. Primary
outcome measures will be biochemically validated 7-day prevalent abstinence rates at the
19-27th and 29-37th week of pregnancy. Secondary outcomes will include 7-day prevalent
abstinence rates at 12 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 12 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.