Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

Opioid-Related Disorders Clinical Trial

Official title:

Methadone, Buprenorphine and Fetal Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067184
• Other study ID #: HBV98112004
• Secondary ID: R01DA019934DPMCD
• Status: Completed
• First received: August 12, 2003
• Last updated: April 24, 2018
• Start date: September 2002
• Est. completion date: August 2010

Study information

• Verified date: April 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Device:
• Toitu 320/325
Fetal monitor

Locations

Country	Name	City	State
United States	Center for Addiction and Pregnancy	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jansson LM, Dipietro J, Elko A. Fetal response to maternal methadone administration. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):611-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetal heart rate		120 minutes
Primary	fetal movement		120 minutes
Secondary	neonatal abstinence syndrome		4 days