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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218621
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 21, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University

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, 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.

Condition or disease Intervention/treatment
Opiate Dependence Pregnancy Procedure: Buprenorphine / methadone

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 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.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior
Study Start Date : September 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Buprenorphine / methadone
    Parallel study to double blind, double dummy study evaluating safety and efficacy of buprenorphine vs methadone treatment for pregnant opioid dependent women

Primary Outcome Measures :
  1. Fetal heart rate [ Time Frame: up to 300 minutes ]
  2. Fetal movement [ Time Frame: up to 300 minutes ]

Secondary Outcome Measures :
  1. Neonatal abstinence syndrome [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Opioid dependent pregnant women enrolled in parent study (Maternal Opioid treatment: Human Experimental Research)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00218621

United States, Maryland
The Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224 6823
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Lauren M. Jansson, M.D. Johns Hopkins University

Responsible Party: Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, Johns Hopkins University Identifier: NCT00218621     History of Changes
Other Study ID Numbers: 04032202
R01DA019934 ( U.S. NIH Grant/Contract )
NIDA R01DA019934
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Lauren M. Jansson, Johns Hopkins University:

Additional relevant MeSH terms:
Opioid-Related Disorders
Neonatal Abstinence Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Infant, Newborn, Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents