Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

Completed

• Conditions: Opioid-Related Disorders

• Registration Number: NCT00067184
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-08-12
• Study First Submitted QC: 2003-08-12
• Study First Posted: 2003-08-13
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

Inclusion Criteria

• Maternal age 18-40 years
• Single intrauterine fetus
• Estimated gestational age of 32 weeks
• DSMIV criteria for opioid dependence according to e-module of the SCID
• Daily methadone maintenance at a stable dose for greater than a week

Exclusion Criteria

• Concurrent DSMIV axis I diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., Alcohol Dependence)
• Presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., HIV infection) that may confound data interpretation
• Evidence of preterm labor
• Evidence of prescription drug use (e.g., antidepressants, tranquilizers)
• Presence of major congenital fetal malformation
• Recent use (last month) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-Trak urine drug toxicology at time of actograph sessions
• Split methadone dosing schedule

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fetal heart rate	120 minutes
fetal movement	120 minutes

Secondary Outcome Measures

Name	Time	Method
neonatal abstinence syndrome	4 days

Trial Locations

Locations (1)

Center for Addiction and Pregnancy; 🇺🇸 Baltimore, Maryland, United States