Viewing Study NCT00067184



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00067184
Status: COMPLETED
Last Update Posted: 2018-04-25
First Post: 2003-08-12

Brief Title: Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Sponsor: Johns Hopkins University
Organization: Johns Hopkins University

Study Overview

Official Title: Methadone Buprenorphine and Fetal Development
Status: COMPLETED
Status Verified Date: 2018-04
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: The purpose of this study is to examine differences in fetal neurobehavior at peak 2 hours after oral dose vs trough 2 hours before oral dose maternal plasma methadone levels
Detailed Description: This study will examine differences in fetal neurobehavior at peak 2 hours after oral dose vs trough 2 hours before oral dose plasma methadone levels Anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels yet the investigators do not understand how in utero methadone exposure affects fetal neurobehavioral state development

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
DPMCDA US NIH GrantContract None httpsreporternihgovquickSearchR01DA019934
R01DA019934 NIH None None