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NCT00218621 Clinical Trial

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

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
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