Status:
COMPLETED
Metabolism of Nicotine and Cotinine in Pregnant African-American Women
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy
Smokers
Eligibility:
FEMALE
18-30 years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 6 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00341640
Start Date
January 6 2005
End Date
December 1 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892