Metabolism of Nicotine and Cotinine in Pregnant African-American Women

June 30, 2017 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Pharmacokinetics of Nicotine and Cotinine in Pregnant African-American Women and Implications for Pharmacological Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Child Health and Human Development (NICHD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 6, 2005

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 999905074
  • 05-CH-N074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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