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Completed

NCT Number: NCT00218621

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

The Center for Addiction and Pregnancy

Baltimore, Maryland, 21224 6823, United States

About this study

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 opiate dependent individuals, and its use during pregnancy is currently being evaluated. Some research has shown that buprenorphine lessens the neonatal abstinence syndrome when compared to methadone. Thirty methadone and 30 buprenorphine maintained women will be evaluated at 24, 28, 32 and 36 weeks gestation using a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate and maternal physiologic parameters. Investigators will be blinded to treatment group. Longitudinal neurodevelopment of the fetuses in each group will be explored. The differential effects of methadone and buprenorphine on the neonatal abstinence syndrome will also be explored.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Buprenorphine / methadone

Procedure

Parallel study to double blind, double dummy study evaluating safety and efficacy of buprenorphine vs methadone treatment for pregnant opioid dependent women

Primary outcomes

  1. Fetal heart rate

    Time frame: up to 300 minutes

  2. Fetal movement

    Time frame: up to 300 minutes

Secondary outcomes

  1. Neonatal abstinence syndrome

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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