Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking; Pregnancy
Intervention: Nicotine Replacement Therapy (Behavioral)
Phase: Phase 2
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Maurice Davis, Phone: (301) 594-9198, Email: firstname.lastname@example.org
This study will compare the effectiveness of counseling plus use of a nicotine patch with
counseling alone for helping pregnant women quit smoking. Smoking during pregnancy is the
most preventable cause of fetal and newborn health problems such as low birth weight, fetal
growth retardation, sudden infant death syndrome, spontaneous abortion, decreased lung
function and premature delivery.
African-American and Hispanic women 18 years of age or older, smoke cigarettes, and live in
the District of Columbia metropolitan area may be eligible for this study. Candidates are
recruited from the George Washington University and Providence Hospital prenatal health
clinics. They are screened with a review of their medical records and a survey that includes
questions about their age, residency, race and ethnicity, educational level and employment
status, number of weeks pregnant, and exposure to cigarette smoke and other types of
Participants answer questions about their smoking behavior, then receive a 10-minute
counseling session and watch a videotape about quitting smoking. Women who are not able to
quit smoking in 1 week are then randomly assigned to one of two treatment groups. One group
continues to receive counseling sessions during the remainder of their pregnancy; the second
group receives nicotine patches as well as the counseling sessions. In addition, all
participants watch a video about smoking and receive a guide to help them quit. Women who
receive the patches must stop smoking completely. If they cannot stop immediately, their
participation in the study ends. The behavioral counseling sessions for all the women are a
series of conversations between the women and a trained counselor to help the woman through
the process of quitting.
Participants are followed during the study with six clinic visits and three telephone calls.
During the first visit, the women answer a series of questions about their smoking habits and
health concerns. A portion of the urine sample they provide during their routine prenatal
visit is used by this study to assess their cotinine (a breakdown product of nicotine)
levels. Saliva and breath samples to test for cotinine and carbon monoxide levels are
collected at each visit. Saliva is collected by brushing the inside of the cheek with a
cotton swab, and breath samples are collected by having the woman blow into a tube connected
to a machine. Participants are evaluated four times during the study with questions about
their smoking behavior.
With the women's permission, their medical records, health, and treatments during pregnancy
are reviewed. At the end of the pregnancy, the infant's weight and health are also reviewed.
Official title: Nicotine Replacement Therapy Methods for Pregnant Minority Women
Study design: Treatment
Primary outcome: Cotinine validated quit rates.
Secondary outcome: Contine validated significant reduction.
The overall focus of the proposed concept submitted by the George Washington University
Medical Center investigators is "The Efficacy of NRT to Reduce the Risk of Nicotine Exposure
in Pregnant Minority Smokers." Prenatal smoke exposure to the fetus and environmental
tobacco smoke exposure of infants and children causes significant harm in both the short- and
long-term. Smoking during pregnancy is the foremost preventable cause of perinatal morbidity
and mortality. There is strong evidence that these exposures are associated with low birth
weight (LBW) and infant mortality, respiratory illness, ear infections, tonsillectomy and
adenoidectomy, asthma, and sudden infant death syndrome (SIDS), developmental delay, and
increased health care utilization and hospitalizations.
George Washington University Medical Center investigators are submitting two concept papers
that aim to test the efficacy of innovative intervention methods tailored to reduce fetal and
infant exposure to nicotine secondary to maternal smoking and environmental tobacco
Minimum age: 21 Years.
Maximum age: N/A.
- INCLUSION CRITERIA
At least 18 years of age
Resident of the District of Columbia or Greater Metropolitan Area
Minority Woman (Either African American or Hispanic)
No more than 24 weeks estimated gestational age
Able to read and speak English
Current cigarette smoker
Baseline saliva continine level equal to or exceeding 30 ng/ml
Expresses desire to quit smoking in this pregnancy
Currently participating in any other smoking cessation treatment program
Has the following conditions: heart disease, irregular heart beat, high blood pressure,
diabetes, liver condition, kidney condition, stomach ulcer, asthma, chronic pulmonary
disease, or skin condition
Currently being treated for psychiatric illness, alcoholism, or other drug addiction.
Locations and Contacts
Maurice Davis, Phone: (301) 594-9198, Email: email@example.com
GW University Medical Center, Washington, District of Columbia 20037, United States; Recruiting
Ayman El-Mohandes, M.D., Sub-Investigator
Susan Blake, Ph.D., Sub-Investigator
Richard Windsor, Ph.D., Sub-Investigator
John Larsen, M.D., Sub-Investigator
Providence Hospital, Washington, District of Columbia, United States; Recruiting
Mathews TJ, Menacker F, MacDorman MF. Infant mortality statistics from the 2000 period linked birth/infant death data set. Natl Vital Stat Rep. 2002 Aug 28;50(12):1-28.
Castles A, Adams EK, Melvin CL, Kelsch C, Boulton ML. Effects of smoking during pregnancy. Five meta-analyses. Am J Prev Med. 1999 Apr;16(3):208-15.
Kleinman JC, Pierre MB Jr, Madans JH, Land GH, Schramm WF. The effects of maternal smoking on fetal and infant mortality. Am J Epidemiol. 1988 Feb;127(2):274-82.
Starting date: August 2005
Last updated: July 18, 2008