SmokingPhase 2NCT00341432
Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers
A Phase 2 study testing Nicotine Replacement Therapy in people with Smoking and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Nicotine Replacement Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2005to 20 Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GW University Medical Center
Washington D.C., District of Columbia, 20037
Providence Hospital
Washington D.C., District of Columbia
About this study
Official title: Nicotine Replacement Therapy Methods for Pregnant Women
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Nicotine Replacement Therapy
- Keywords
- NRT Study, Smoking Cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cotinine validated quit rates.
Secondary outcomes (1)
Contine validated significant reduction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start16 Aug 2005
- Study completion20 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341432
- Sponsor's protocol ID
- 999905227
- Other IDs
- 05-CH-N227
- Status last verified
- 20 Apr 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 12224408Castles 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.
PubMed 10198660Kleinman 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.
PubMed 3337083El-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.
PubMed 22761006Tan 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.
PubMed 21928117
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Replacement Therapy Methods for Pregnant Women
- ClinicalTrials.gov ID
- NCT00341432
- Acronym / sponsor ID
- 999905227
- Keywords
- NRT Study, Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 16 Aug 2005
- Study completion
- 20 Apr 2011 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy | Behavioural | – |
Primary outcome
Cotinine validated quit rates.
1 secondary outcome
Contine validated significant reduction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12224408Mathews 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.
- Background: PubMed 10198660Castles 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.
- Background: PubMed 3337083Kleinman 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.
- Derived from this study: PubMed 22761006El-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.
- Derived from this study: PubMed 21928117Tan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine Replacement Therapy in people with Smoking and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cotinine validated quit rates.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341432, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.