Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

Completed

Conditions studied: Opioid-Related Disorders

In brief

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.

Key facts

Study ID

NCT00067184

Run by

Johns Hopkins University

People needed

157

Starts

2002-09-01

Expected to finish

2010-08-01

Last updated by the study team

2018-04-25

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Addiction and Pregnancy — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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