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Metabolism of Nicotine and Cotinine in Pregnant African-American Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00341640
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date  ICMJE June 19, 2006
First Posted Date  ICMJE June 21, 2006
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE January 6, 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolism of Nicotine and Cotinine in Pregnant African-American Women
Official Title  ICMJE Pharmacokinetics of Nicotine and Cotinine in Pregnant African-American Women and Implications for Pharmacological Interventions
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Pregnancy
  • Smokers
Intervention  ICMJE Procedure: Blood testing
Study Arms  ICMJE Not Provided
Publications * Eskenazi B, Prehn AW, Christianson RE. Passive and active maternal smoking as measured by serum cotinine: the effect on birthweight. Am J Public Health. 1995 Mar;85(3):395-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†19,¬†2006)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 1, 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:

English-speaking, self-identified African-American women smokers, age 18 to 30 years, with singleton, uncomplicated pregnancies in the second trimester will be eligible.

Only women receiving routine prenatal care, begun by 16 weeks gestation, will be included.

Women will be asked to release records of their pregnancy to study staff for review prior to enrollment.

All participating women will receive clearance from their obstetrician before enrollment.

EXCLUSION CRITERIA:

Women who report use of any other substance of abuse besides nicotine will be ineligible.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00341640
Other Study ID Numbers  ICMJE 999905074
05-CH-N074
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 1, 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP