Fetal Neurobehavioral Development in Methadone Maintained Pregnancies



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 40
Updated:4/27/2018
Start Date:September 2002
End Date:August 2010

Use our guide to learn which trials are right for you!

Methadone, Buprenorphine and Fetal Development

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.

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.

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
We found this trial at
1
site
Baltimore, Maryland 21224
?
mi
from
Baltimore, MD
Click here to add this to my saved trials