The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00218621
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 20
• Location: 1
• Duration (Months): 41
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. The subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal biophysiologic data longitudinally during pregnancy to determine how these substances may affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements of infant vagal tone will be collected to see how methadone and buprenorphine differentially affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence; Pregnancy	Procedure: Buprenorphine / methadone

Detailed Description

Previous research by this group has found that methadone treatment during pregnancy directly impacts fetal neurophysiology independently of maternal physiology. Buprenorphine is a new therapy for opiate dependent individuals, and its use during pregnancy is currently being evaluated. Some research has shown that buprenorphine lessens the neonatal abstinence syndrome when compared to methadone. Thirty methadone and 30 buprenorphine maintained women will be evaluated at 24, 28, 32 and 36 weeks gestation using a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate and maternal physiologic parameters. Investigators will be blinded to treatment group. Longitudinal neurodevelopment of the fetuses in each group will be explored. The differential effects of methadone and buprenorphine on the neonatal abstinence syndrome will also be explored.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Outcome Measures

Primary Outcome Measures

1. Fetal heart rate [up to 300 minutes]

2. Fetal movement [up to 300 minutes]

Secondary Outcome Measures

1. Neonatal abstinence syndrome [4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• generally healthy opiate dependent women

• currently enrolled in the study "Maternal Opioid Treatment, Human Experimental Research study

• uncomplicated singleton pregnancies

Exclusion Criteria:

• complications of pregnancy, including HIV, diabetes, polyhydramnios, hypertension, preterm labor or placenta previa

• evidence of fetal malformation

• significant maternal health problems, including HIV infection

• significant maternal psychopathology that would preclude informed consent, including schizophrenia

• alcohol dependency per DSM IV criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Center for Addiction and Pregnancy	Baltimore	Maryland	United States	21224 6823

Sponsors and Collaborators

• Johns Hopkins University
• National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00218621
• Other Study ID Numbers: 04032202; R01DA019934; NIDA R01DA019934; DPMCDA
• First Posted: Sep 22, 2005
• Last Update Posted: Feb 21, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, Johns Hopkins University: Buprenorphine; Methadone
• Additional relevant MeSH terms: Opioid-Related Disorders; Buprenorphine; Methadone

Study Results

No Results Posted as of Feb 21, 2013