Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers

2014-08-27 03:43:58 | BioPortfolio


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 tobacco.

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.


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 exposure.

Study Design

Primary Purpose: Treatment




Nicotine Replacement Therapy


GW University Medical Center
District of Columbia
United States




National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:43:58-0400

Clinical Trials [1681 Associated Clinical Trials listed on BioPortfolio]

Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia

This proposal seeks to evaluate a pilot smoking cessation treatment program that will combine nicotine replacement therapy with or without bupropion sustained-release (SR) with cognitive b...

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more...

In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking ...

Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT...

Pilot Study of a New Nicotine Replacement Therapy

Pilot study of a new nicotine replacement therapy for smoking cessation.

PubMed Articles [11054 Associated PubMed Articles listed on BioPortfolio]

Comparison of nicotine exposure during pregnancy when smoking and abstinent with nicotine replacement therapy: systematic review and meta-analysis.

Smoking during pregnancy is strongly associated with negative pregnancy and perinatal outcomes. Some guidelines recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy but ...

Nicotine replacement therapy versus control for smoking cessation.

Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from ciga...

Exposure to positive peer sentiment about nicotine replacement therapy in an online smoking cessation community is associated with NRT use.

Little is known about the influence of online peer interactions on health behavior change. This study examined the relationship between exposure to peer sentiment about nicotine replacement therapy (N...

The effectiveness of Cytisine versus Nicotine Replacement Treatment for smoking cessation in the Russian Federation.

There is just one study comparing the effectiveness of cytisine and nicotine replacement therapy (NRT) for smoking cessation. In the Russian Federation, both products are widely available as over-the-...

The contribution of agonist and antagonist activities of α4β2* nAChR ligands to smoking cessation efficacy: a quantitative analysis of literature data.

Two mechanisms underlie smoking cessation efficacies of α4β2* nicotinic acetylcholine receptor (nAChR) agonists: a "nicotine-like" agonist activity reduces craving by substituting for nicotine durin...

Medical and Biotech [MESH] Definitions

SMOKING of non-TOBACCO (or NICOTINE-containing) substances.


Therapeutic replacement or supplementation of defective or missing enzymes to alleviate the effects of the enzyme deficiency (e.g., GLUCOSYLCERAMIDASE replacement for GAUCHER DISEASE).

A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

More From BioPortfolio on "Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers"

Quick Search


Relevant Topics

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial