PregnancyPhase 1NCT00341640
Metabolism of Nicotine and Cotinine in Pregnant African-American Women
A Phase 1 study testing Blood testing in people with Pregnancy and Smokers, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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 studies have shown that pregnancy, race and ethnicity can affect the way people metabolize nicotine. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- What is being tested?
- Blood testing
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2005to 1 Dec 2006
- Phase
- Phase 1
- 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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Women who report use of any other substance of abuse besides nicotine will be ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
Official title: Pharmacokinetics of Nicotine and Cotinine in Pregnant African-American Women and Implications for Pharmacological Interventions
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 studies have shown that pregnancy, race and ethnicity can affect the way people metabolize nicotine. The information from this study may help scientists develop ways to help pregnant African-American women quit smoking and not start smoking again after delivery.
African-American women 18-30years of age who are in the second trimester of a healthy pregnancy, who are carrying only one baby and who smoke 10 or more cigarettes a day may be eligible for this study. Candidates are screened with a medical history, physical examination and urine test. They receive counseling to help them quit smoking. Those who cannot quit smoking within 7 to 10 days after receiving counseling may be invited to join the study.
Read more
Participants are admitted to a private room in the Pediatric Clinical Research Center at Children's National Medical Center in Washington, D.C., for 48 hours, during which time they are not permitted to smoke. After a "wash out" period, a nicotine patch will be applied according to these doses and schedules:
- 21 mg patch for 24 hours
- 21 mg patch for 16 hours
- 14 mg patch for 24 hours
- 14 mg patch for 16 hours
An intravenous (IV) line is placed in the subject's arm and 12 blood samples are drawn through the line at intervals during the 48 hours. Twleve urine and saliva samples are also collected. Blood, urine, and saliva samples are analyzed for nicotine and cotinine (a product of nicotine metabolism) levels, and DNA will be collected studied for genes that are associated with nicotine and cotinine metabolism. Participants are interviewed about their urges to smoke, quality of sleep, etc.
Read the detailed description
This is a two-part protocol. This protocol is for Part A, the specific aims of which are to:
- Determine the optimal dose (21 mg or 14 mg) and duration (24 hours or 16 hours) of nicotine replacement using the nicotine transdermal delivery device for African-American pregnant women who smoke, and
- Determine the implications of the nicotine replacement studies for treatment with the nicotine replacement patch of African-American women who smoke during pregnancy.
Additional aims are to:
- Collect DNA for exploratory analyses regarding genetic causes of differences in metabolism of nicotine and cotinine.
Latina/Hispanic women will not be included in this study because a) few smoke, and b) few are seen in the clinical sites from which participants will be recruited.
- Being tested
- Blood testing
- Keywords
- Teen Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testingProcedure or surgery
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 start6 Jan 2005
- Study completion1 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 50 participants
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
- NCT00341640
- Sponsor's protocol ID
- 999905074
- Other IDs
- 05-CH-N074
- Status last verified
- 1 Dec 2006
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Eskenazi B, Prehn AW, Christianson RE. Passive and active maternal smoking as measured by serum cotinine: the effect on birthweight. Am J Public Health. 1995 Mar;85(3):395-8. doi: 10.2105/ajph.85.3.395.
PubMed 7892926
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
- Pharmacokinetics of Nicotine and Cotinine in Pregnant African-American Women and Implications for Pharmacological Interventions
- ClinicalTrials.gov ID
- NCT00341640
- Acronym / sponsor ID
- 999905074
- Keywords
- Teen Pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 6 Jan 2005
- Study completion
- 1 Dec 2006
- 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 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 studies have shown that pregnancy, race and ethnicity can affect the way people metabolize nicotine. The information from this study may help scientists develop ways to help pregnant African-American women quit smoking and not start smoking again after delivery.
African-American women 18-30years of age who are in the second trimester of a healthy pregnancy, who are carrying only one baby and who smoke 10 or more cigarettes a day may be eligible for this study. Candidates are screened with a medical history, physical examination and urine test. They receive counseling to help them quit smoking. Those who cannot quit smoking within 7 to 10 days after receiving counseling may be invited to join the study.
Participants are admitted to a private room in the Pediatric Clinical Research Center at Children's National Medical Center in Washington, D.C., for 48 hours, during which time they are not permitted to smoke. After a "wash out" period, a nicotine patch will be applied according to these doses and schedules:
- 21 mg patch for 24 hours
- 21 mg patch for 16 hours
- 14 mg patch for 24 hours
- 14 mg patch for 16 hours
An intravenous (IV) line is placed in the subject's arm and 12 blood samples are drawn through the line at intervals during the 48 hours. Twleve urine and saliva samples are also collected. Blood, urine, and saliva samples are analyzed for nicotine and cotinine (a product of nicotine metabolism) levels, and DNA will be collected studied for genes that are associated with nicotine and cotinine metabolism. Participants are interviewed about their urges to smoke, quality of sleep, etc.
Detailed description
This is a two-part protocol. This protocol is for Part A, the specific aims of which are to:
- Determine the optimal dose (21 mg or 14 mg) and duration (24 hours or 16 hours) of nicotine replacement using the nicotine transdermal delivery device for African-American pregnant women who smoke, and
- Determine the implications of the nicotine replacement studies for treatment with the nicotine replacement patch of African-American women who smoke during pregnancy.
Additional aims are to:
- Collect DNA for exploratory analyses regarding genetic causes of differences in metabolism of nicotine and cotinine.
Latina/Hispanic women will not be included in this study because a) few smoke, and b) few are seen in the clinical sites from which participants will be recruited.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who report use of any other substance of abuse besides nicotine will be ineligible.
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 |
|---|---|---|
| Blood testing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 7892926Eskenazi B, Prehn AW, Christianson RE. Passive and active maternal smoking as measured by serum cotinine: the effect on birthweight. Am J Public Health. 1995 Mar;85(3):395-8. doi: 10.2105/ajph.85.3.395.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood testing in people with Pregnancy and Smokers, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site 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 4 inclusion and 1 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341640, which also lists 1 linked publication.
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.