NCT00067184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2003

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

7.9 years

First QC Date

August 12, 2003

Last Update Submit

April 24, 2018

Conditions

Opioid-Related Disorders

Keywords

methadonefetus

Outcome Measures

Primary Outcomes (2)

  • fetal heart rate

    120 minutes

  • fetal movement

    120 minutes

Secondary Outcomes (1)

  • neonatal abstinence syndrome

    4 days

Interventions

Toitu 320/325DEVICE

Fetal monitor

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Methadone exposed pregnancies

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Pregnancy

Baltimore, Maryland, 21224, United States

Location

Related 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. doi: 10.1016/j.ajog.2005.02.075.

    PMID: 16150250RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Lauren M. Jansson, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2003

First Posted

August 13, 2003

Study Start

September 1, 2002

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

US(1)