Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

April 24, 2018 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Center for Addiction and Pregnancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Methadone exposed pregnancies

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fetal heart rate
Time Frame: 120 minutes
120 minutes
fetal movement
Time Frame: 120 minutes
120 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
neonatal abstinence syndrome
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Lauren M. Jansson, M.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 12, 2003

First Submitted That Met QC Criteria

August 12, 2003

First Posted (Estimate)

August 13, 2003

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV98112004
  • DPMCDA (Other Identifier: NIDA)
  • R01DA019934 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid-Related Disorders

Clinical Trials on Toitu 320/325

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe