Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218010
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-16
Brief Title:
Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Breastfeeding Among Methadone Maintained Women
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Methadone is a drug that offers significant therapeutic benefits to opiate dependent women who are pregnant Currently it is the treatment of choice for this group of people The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction In addition this study will evaluate the effects of methadone on infant neurobehavior
Detailed Description:
Methadone is a drug that is commonly used to treat opiate addiction usually as part of a detoxification and maintenance program Methadone offers significant therapeutic benefits to pregnant women who are opiate dependent and it is currently the treatment of choice for this group of people In general breast milk is beneficial for infants However there is some concern as to whether it is safe for women who are taking methadone to breastfeed their babies The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction In addition this study will evaluate the effects of methadone on infant neurobehavior
Participants will be assigned to one of two groups women taking methadone who will breastfeed their babies or women taking methadone who will bottle-feed their babies On Days 1 2 3 4 14 and 30 following infant delivery plasma will be collected from both groups and breast milk will be collected from the breastfeeding group These samples will be quantitatively analyzed for methadone Infants will undergo neurobehavioral assessments on Days 3 14 and 30 following birth Rates and severity of neonatal abstinence syndrome will also be evaluated
Participants will be assigned to one of two groups women taking methadone who will breastfeed their babies or women taking methadone who will bottle-feed their babies On Days 1 2 3 4 14 and 30 following infant delivery plasma will be collected from both groups and breast milk will be collected from the breastfeeding group These samples will be quantitatively analyzed for methadone Infants will undergo neurobehavioral assessments on Days 3 14 and 30 following birth Rates and severity of neonatal abstinence syndrome will also be evaluated
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