Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid-Related Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Toitu 320/325

Fetal monitor

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No