The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1

Completed

Conditions studied: Opiate Dependence, Pregnancy

In brief

The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. The subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal biophysiologic data longitudinally during pregnancy to determine how these substances may affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements of infant vagal tone will be collected to see how methadone and buprenorphine differentially affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.

Key facts

Study ID

NCT00218621

Run by

Johns Hopkins University

People needed

20

Starts

2005-09-01

Expected to finish

2009-02-01

Last updated by the study team

2013-02-21

Who can join

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

You may qualify if…

• generally healthy opiate dependent women
• currently enrolled in the study "Maternal Opioid Treatment, Human Experimental Research study
• uncomplicated singleton pregnancies

You may not qualify if…

• complications of pregnancy, including HIV, diabetes, polyhydramnios, hypertension, preterm labor or placenta previa
• evidence of fetal malformation
• significant maternal health problems, including HIV infection
• significant maternal psychopathology that would preclude informed consent, including schizophrenia
• alcohol dependency per DSM IV criteria

Where it is running

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

Full record on ClinicalTrials.gov

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