Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341640
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Metabolism of Nicotine and Cotinine in Pregnant African-American Women
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pharmacokinetics of Nicotine and Cotinine in Pregnant African-American Women and Implications for Pharmacological Interventions
Status:
COMPLETED
Status Verified Date:
2006-12-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Childrens National Medical Center in Washington DC 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 subjects 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
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 Childrens National Medical Center in Washington DC 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 subjects 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
1 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
2 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
1 Collect DNA for exploratory analyses regarding genetic causes of differences in metabolism of nicotine and cotinine
LatinaHispanic 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
1 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
2 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
1 Collect DNA for exploratory analyses regarding genetic causes of differences in metabolism of nicotine and cotinine
LatinaHispanic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CH-N074 | None | None | None |