Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
This study has been completed.
Information provided by (Responsible Party):
Lauren M. Jansson, National Institute on Drug Abuse (NIDA)
First received: August 12, 2003
Last updated: February 20, 2013
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.
Device: Toitu 320/325
||Observational Model: Cohort
Time Perspective: Prospective
||Methadone, Buprenorphine and Fetal Development
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2010 (Final data collection date for primary outcome measure)
Device: Toitu 320/325
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Methadone exposed pregnancies
Actively enrolled pregnant patients in CAP SA treatment.
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00067184
|Center for Addiction and Pregnancy
|Baltimore, Maryland, United States, 21224 |
Johns Hopkins University
||Lauren M. Jansson, M.D.
||Johns Hopkins University
||Lauren M. Jansson, Associate Professr of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA)
History of Changes
|Other Study ID Numbers:
||HBV98112004, R01DA019934, DPMCDA
|Study First Received:
||August 12, 2003
||February 20, 2013
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 29, 2014