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

NCT00341432 | Completed Phase 2

• 2 other identifiers: 99990522705-CH-N227
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Smoking; Pregnancy

Keywords

NRT Study; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Cotinine validated quit rates.

Secondary Outcomes (1)

• Contine validated significant reduction.

Interventions

Nicotine Replacement Therapy BEHAVIORAL

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 30 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

GW University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Providence Hospital

Washington D.C., District of Columbia, United States

Location

Related Publications (5)

• 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.

  PMID: 12224408 BACKGROUND

• 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. doi: 10.1016/s0749-3797(98)00089-0.

  PMID: 10198660 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.aje.a114803.

  PMID: 3337083 BACKGROUND

• El-Mohandes AA, Windsor R, Tan S, Perry DC, Gantz MG, Kiely M. A randomized clinical trial of trans-dermal nicotine replacement in pregnant African-American smokers. Matern Child Health J. 2013 Jul;17(5):897-906. doi: 10.1007/s10995-012-1069-9.

  PMID: 22761006 DERIVED

• Tan S, Courtney LP, El-Mohandes AA, Gantz MG, Blake SM, Thornberry J, El-Khorazaty MN, Perry D, Kiely M. Relationships between self-reported smoking, household environmental tobacco smoke exposure and depressive symptoms in a pregnant minority population. Matern Child Health J. 2011 Dec;15 Suppl 1:S65-74. doi: 10.1007/s10995-011-0876-8.

  PMID: 21928117 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: August 16, 2005
• Study Completion: April 20, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-04-20

Locations

US (2)