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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00218621
First received: September 20, 2005
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Opiate Dependence
Pregnancy
 Procedure: Buprenorphine / methadone
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Fetal heart rate [ Time Frame: up to 300 minutes ] [ Designated as safety issue: No ]
  • Fetal movement [ Time Frame: up to 300 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neonatal abstinence syndrome [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218621

Locations
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)
Investigators
Principal Investigator: Lauren M. Jansson, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00218621     History of Changes
Other Study ID Numbers: 04032202, R01DA019934, NIDA R01DA019934, DPMCDA
Study First Received: September 20, 2005
Last Updated: February 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Buprenorphine
Methadone

Additional relevant MeSH terms:
Neonatal Abstinence Syndrome
Opioid-Related Disorders
Infant, Newborn, Diseases
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013