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

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218621

Purpose

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	Intervention	Phase
Opiate Dependence Pregnancy	Procedure: Buprenorphine / methadone	Phase II

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Fetal heart rate [ Time Frame: up to 300 minutes ] [ Designated as safety issue: No ]
Fetal movement [ Time Frame: up to 300 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neonatal abstinence syndrome [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	September 2005
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Opioid dependent pregnant women enrolled in parent study (Maternal Opioid treatment: Human Experimental Research)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218621

Locations

United States, Maryland
The Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224 6823

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Lauren M. Jansson, M.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Lauren Jansson / Associate Professor of Pediatrics, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier:	NCT00218621 History of Changes
Other Study ID Numbers:	04032202, NIDA R01DA019934, DPMCDA
Study First Received:	September 20, 2005
Last Updated:	April 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Buprenorphine
Methadone

Additional relevant MeSH terms:

Neonatal Abstinence Syndrome
Opioid-Related Disorders
Infant, Newborn, Diseases
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012