Metabolism of Nicotine and Cotinine in Pregnant African-American Women
Condition: Pregnancy; Smokers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will provide information regarding the optimal dose and duration of nicotine
      replacement using the nicotine patch for a smoking cessation study of pregnant
      African-American women. Previous studies have shown that pregnancy, race and ethnicity can
      affect the way people metabolize nicotine. The information from this study may help
      scientists develop ways to help pregnant African-American women quit smoking and not start
      smoking again after delivery.

      African-American women 18-30years of age who are in the second trimester of a healthy
      pregnancy, who are carrying only one baby and who smoke 10 or more cigarettes a day may be
      eligible for this study. Candidates are screened with a medical history, physical examination
      and urine test. They receive counseling to help them quit smoking. Those who cannot quit
      smoking within 7 to 10 days after receiving counseling may be invited to join the study.

      Participants are admitted to a private room in the Pediatric Clinical Research Center at
      Children's National Medical Center in Washington, D.C., for 48 hours, during which time they
      are not permitted to smoke. After a "wash out" period, a nicotine patch will be applied
      according to these doses and schedules:

        -  21 mg patch for 24 hours

        -  21 mg patch for 16 hours

        -  14 mg patch for 24 hours

        -  14 mg patch for 16 hours

      An intravenous (IV) line is placed in the subject's arm and 12 blood samples are drawn
      through the line at intervals during the 48 hours. Twleve urine and saliva samples are also
      collected. Blood, urine, and saliva samples are analyzed for nicotine and cotinine (a product
      of nicotine metabolism) levels, and DNA will be collected studied for genes that are
      associated with nicotine and cotinine metabolism. Participants are interviewed about their
      urges to smoke, quality of sleep, etc.
    

Detailed description: 
      This is a two-part protocol. This protocol is for Part A, the specific aims of which are to:

        1. Determine the optimal dose (21 mg or 14 mg) and duration (24 hours or 16 hours) of
           nicotine replacement using the nicotine transdermal delivery device for African-American
           pregnant women who smoke, and

        2. Determine the implications of the nicotine replacement studies for treatment with the
           nicotine replacement patch of African-American women who smoke during pregnancy.

      Additional aims are to:

      1. Collect DNA for exploratory analyses regarding genetic causes of differences in metabolism
      of nicotine and cotinine.

      Latina/Hispanic women will not be included in this study because a) few smoke, and b) few are
      seen in the clinical sites from which participants will be recruited.
    

Intervention name(s): Blood testing
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: Teen Pregnancy