Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lauren M. Jansson, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00067184
First received: August 12, 2003
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 ] [ Designated as safety issue: No ]
  • fetal movement [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

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

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.

  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

Methadone exposed pregnancies

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067184

Locations
United States, Maryland
Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lauren M. Jansson, M.D. Johns Hopkins University
  More Information

Publications:
Responsible Party: Lauren M. Jansson, Associate Professr of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00067184     History of Changes
Other Study ID Numbers: HBV98112004, R01DA019934, DPMCDA
Study First Received: August 12, 2003
Last Updated: February 20, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 31, 2014