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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218621 |
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 |
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Opiate Dependence Pregnancy |
Procedure: Buprenorphine / methadone |
Phase II |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Maternal Buprenorphine Administration and Fetal/Infant Neurobehavior |
Estimated Enrollment: | 60 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Opioid dependent pregnant women enrolled in parent study (Maternal Opioid treatment: Human Experimental Research)
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
The Center for Addiction and Pregnancy | Recruiting |
Baltimore, Maryland, United States, 21224 6823 | |
Contact: Lauren M Jansson, M.D. 410-550-5438 ljansson@jhmi.edu | |
Contact: Erica Williams 410 550-8779 ewilli77@jhmi.edu |
Principal Investigator: | Lauren M. Jansson, M.D. | Johns Hopkins University |
Responsible Party: | Johns Hopkins University School of Medicine ( Lauren Jansson / Asistant Professor of Pediatrics ) |
Study ID Numbers: | 04032202, NIDA R01DA019934 |
Study First Received: | September 20, 2005 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00218621 |
Health Authority: | United States: Federal Government |
Buprenorphine Methadone |
Disorders of Environmental Origin Opioid-Related Disorders Naphazoline Methadone Oxymetazoline Buprenorphine Neonatal Abstinence Syndrome |
Mental Disorders Phenylephrine Guaifenesin Substance-Related Disorders Infant, Newborn, Diseases Phenylpropanolamine |
Respiratory System Agents Physiological Effects of Drugs Narcotic Antagonists Central Nervous System Depressants Narcotics Pharmacologic Actions Sensory System Agents |
Therapeutic Uses Analgesics Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Analgesics, Opioid |