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

NCT ID: NCT00218621

Last Updated: 2013-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-02-28

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.

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.

Conditions

Opiate Dependence; Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Buprenorphine / methadone

Parallel study to double blind, double dummy study evaluating safety and efficacy of buprenorphine vs methadone treatment for pregnant opioid dependent women

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Lauren M. Jansson

Associate Professor of Pediatrics Johns Hopkins University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren M. Jansson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Center for Addiction and Pregnancy

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01DA019934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA R01DA019934

Identifier Type: -

Identifier Source: secondary_id

DPMCDA

Identifier Type: -

Identifier Source: secondary_id

04032202

Identifier Type: -

Identifier Source: org_study_id