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Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

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.
 
ClinicalTrials.gov Identifier: NCT00067184
Recruitment Status : Completed
First Posted : August 13, 2003
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment
Opioid-Related Disorders Device: Toitu 320/325

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 the investigators do not understand how in utero methadone exposure affects fetal neurobehavioral state development.

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Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Methadone, Buprenorphine and Fetal Development
Study Start Date : September 2002
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Methadone


Intervention Details:
  • Device: Toitu 320/325
    Fetal monitor


Primary Outcome Measures :
  1. fetal heart rate [ Time Frame: 120 minutes ]
  2. fetal movement [ Time Frame: 120 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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00067184


Locations
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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)
Investigators
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Principal Investigator: Lauren M. Jansson, M.D. Johns Hopkins University
Publications of Results:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00067184    
Other Study ID Numbers: HBV98112004
R01DA019934 ( U.S. NIH Grant/Contract )
DPMCDA
First Posted: August 13, 2003    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by Johns Hopkins University:
methadone
fetus
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders