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Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), October 2008

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00067184
  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

Drug Information available for:   Methadone    Methadone hydrochloride    Buprenorphine    Buprenorphine hydrochloride   

U.S. FDA Resources

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

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   180
Study Start Date:   September 2002
Estimated Study Completion Date:   August 2010

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

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

Contacts
Contact: Lauren M. Jansson, M.D.     (410)550-5438     ljansson@jhmi.edu    

Locations
United States, Maryland
Center for Addiction and Pregnancy     Recruiting
      Baltimore, Maryland, United States, 21224
      Contact: Lauren M. Jansson, M.D.     410-550-5438     ljansson@jhmi.edu    

Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Johns Hopkins University

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


Responsible Party:   Johns Hopkins University School of Medicine ( Lauren Jansson / Assistant Professor of Pediatrics )
Study ID Numbers:   HBV98112004, NIDA R01DA019934
First Received:   August 12, 2003
Last Updated:   October 1, 2008
ClinicalTrials.gov Identifier:   NCT00067184
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Methadone
Buprenorphine
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders

ClinicalTrials.gov processed this record on November 30, 2008




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