Fetal and Infant Effects of Maternal Buprenorphine Treatment

Completed · Phase 2/Phase 3

Conditions studied: Neonatal Abstinence Syndrome

In brief

This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth.

Key facts

Study ID

NCT01561079

Run by

Johns Hopkins University

People needed

127

Starts

2012-02-01

Expected to finish

2016-06-01

Last updated by the study team

2017-09-26

Who can join

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

You may qualify if…

• Current opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-R criteria
• 18-40 years of age with uncomplicated singleton pregnancies
• Accurate gestational age dating verified by ultrasound
• Gestation of less than 34 weeks
• Stabilization on buprenorphine for one week prior to study procedures

You may not qualify if…

• Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery (i.e. incompetent cervix)
• Evidence of fetal malformation detected by prenatal ultrasound
• Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension.
• Significant maternal psychopathology that would preclude informed consent (i.e. schizophrenia)
• Alcohol dependency per DSM IV R criteria (see ascertainment methods below)
• Women stable on methadone maintenance (defined as more than 3 days of methadone dosing)
• Women entering drug treatment reporting using "street" methadone (for more than 3 days)

Where it is running

• Center for Addiction and Pregnancy — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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