Fetal Neurobehavioral Development in Methadone Maintained Pregnancies - Tabular View

Tracking Information

First Received Date ^ICMJE

August 12, 2003

Last Updated Date

November 2, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

fetal heart rate
fetal movement

Change History

Complete list of historical versions of study NCT00067184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

neonatal abstinence syndrome

Descriptive Information

Brief Title ^ICMJE

Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

Official Title ^ICMJE

Methadone, Buprenorphine and Fetal Development

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Device: Toitu 320/325

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

August 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00067184

Responsible Party

Lauren Jansson / Associate Professor of Pediatrics, Johns Hopkins University School of Medicine

Study ID Numbers ^ICMJE

HBV98112004, R01 DA019934, DPMCDA

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Johns Hopkins University

Investigators ^ICMJE

Principal Investigator:

Lauren M. Jansson, M.D.

Johns Hopkins University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP