Status:
COMPLETED
The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opiate Dependence
Pregnancy
Eligibility:
FEMALE
18-40 years
Brief Summary
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...
Detailed Description
Previous research by this group has found that methadone treatment during pregnancy directly impacts fetal neurophysiology independently of maternal physiology. Buprenorphine is a new therapy for opia...
Eligibility Criteria
Inclusion
- generally healthy opiate dependent women
- currently enrolled in the study "Maternal Opioid Treatment, Human Experimental Research study
- uncomplicated singleton pregnancies
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00218621
Start Date
September 1 2005
End Date
February 1 2009
Last Update
February 21 2013
Active Locations (1)
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1
The Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224 6823