Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

Methadone, Buprenorphine and Fetal Development

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00067184

Enrollment

157

Registered

2003-08-13

Start date

2002-09-30

Completion date

2010-08-31

Last updated

2018-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Related Disorders

Keywords

methadone, fetus

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.

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.

Interventions

DEVICEToitu 320/325

Fetal monitor

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
fetal heart rate	120 minutes
fetal movement	120 minutes

Secondary

Measure	Time frame
neonatal abstinence syndrome	4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026