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Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lauren M. Jansson, National Institute on Drug Abuse (NIDA) Identifier:
First received: August 12, 2003
Last updated: March 30, 2015
Last verified: February 2013
The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.

Condition Intervention
Opioid-Related Disorders
Device: Toitu 320/325

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Methadone, Buprenorphine and Fetal Development

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • fetal heart rate [ Time Frame: 120 minutes ]
  • fetal movement [ Time Frame: 120 minutes ]

Secondary Outcome Measures:
  • neonatal abstinence syndrome [ Time Frame: 4 days ]

Enrollment: 157
Study Start Date: September 2002
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Toitu 320/325
    Fetal monitor
Detailed Description:
This study will examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) plasma methadone levels. Anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels, yet we do not understand how in utero methadone exposure affects fetal neurobehavioral state development.

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
Methadone exposed pregnancies

Actively enrolled pregnant patients in CAP SA treatment.

Inclusion Criteria:

  • Maternal age 18-40 years
  • Single intrauterine fetus
  • Estimated gestational age of 32 weeks
  • DSMIV criteria for opioid dependence according to e-module of the SCID
  • Daily methadone maintenance at a stable dose for greater than a week

Exclusion Criteria:

  • Concurrent DSMIV axis I diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., Alcohol Dependence)
  • Presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., HIV infection) that may confound data interpretation
  • Evidence of preterm labor
  • Evidence of prescription drug use (e.g., antidepressants, tranquilizers)
  • Presence of major congenital fetal malformation
  • Recent use (last month) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-Trak urine drug toxicology at time of actograph sessions
  • Split methadone dosing schedule
  Contacts and Locations
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Please refer to this study by its identifier: NCT00067184

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

Responsible Party: Lauren M. Jansson, Associate Professr of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA) Identifier: NCT00067184     History of Changes
Other Study ID Numbers: HBV98112004
R01DA019934 ( US NIH Grant/Contract Award Number )
Study First Received: August 12, 2003
Last Updated: March 30, 2015

Keywords provided by Johns Hopkins University:

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents processed this record on April 28, 2017