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

Pregnancy Clinical Trial

Official title:

Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218621
• Other study ID #: 04032202
• Secondary ID: R01DA019934NIDA
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: February 20, 2013
• Start date: September 2005
• Est. completion date: February 2009

Study information

• Verified date: February 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Opiate Dependence
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	The Center for Addiction and Pregnancy	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal heart rate		up to 300 minutes	No
Primary	Fetal movement		up to 300 minutes	No
Secondary	Neonatal abstinence syndrome		4 days	No