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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00067184
Other study ID # HBV98112004
Secondary ID R01DA019934DPMCD
Status Completed
Phase
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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