Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), November 2009

First Received: August 12, 2003 Last Updated: November 2, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Johns Hopkins University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00067184

Purpose

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.

Condition	Intervention
Opioid-Related Disorders	Device: Toitu 320/325

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Methadone, Buprenorphine and Fetal Development

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

fetal heart rate [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
fetal movement [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

neonatal abstinence syndrome [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	180
Study Start Date:	September 2002
Estimated Study Completion Date:	August 2010

Intervention Details:

Fetal monitor

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 we do not understand how in utero methadone exposure affects fetal neurobehavioral state development.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Methadone exposed pregnancies

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067184

Contacts

Contact: Lauren M Jansson, M.D.	(410)550-5438	ljansson@jhmi.edu
Contact: Erica Williams	(410)550-8779	ewilli77@jhmi.edu

Locations

United States, Maryland
Center for Addiction and Pregnancy	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Lauren M. Jansson, M.D. 410-550-5438 ljansson@jhmi.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators

Principal Investigator:

Lauren M. Jansson, M.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University School of Medicine ( Lauren Jansson / Associate Professor of Pediatrics )
Study ID Numbers:	HBV98112004, R01 DA019934, DPMCDA
Study First Received:	August 12, 2003
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00067184 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Methadone
Sensory System Agents

Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 25, 2009