Current Research Projects
Improving Outcomes in Neonatal Abstinence Syndrome
This is a National Institute of Drug Abuse (NIDA) funded randomized double blinded clinical trial comparing methadone versus morphine as best first-line treatment for infants with NAS. The primary goal of the trial is to establish best practice for NAS and to gain FDA approval for these medications for NAS. Secondary aims include evaluating genetic predictors of NAS outcomes, and evaluating neurodevelopmental outcomes at 18 months of age. NIDA grant number R01DA032889-01A1.
1. Status: Actively enrolling
2. Contact: Elisha.Wachman@bmc.org
3. Gov: NCT01958476
The Genetics of Neonatal Abstinence Syndrome
This is a multi-center study evaluating the genetic and epigenetic predictors of NAS outcomes in opioid-exposed mother-infant dyads. Funding is provided by the Joel Alpert Foundation and the BU Genome Science Institute.
1. Status: Actively enrolling
2. Contact: Elisha.Wachman@bmc.org
Perinatal Substance Exposure Placental Study
This study is examining how maternal exposures during pregnancy such as cigarette smoking, opiate dependence and hepatitis C can impact placental development and function, and subsequently contribute to adverse neonatal outcomes such as fetal growth restriction (FGR), neonatal abstinence syndrome and transmission of hepatitis C.
1. Status: Actively enrolling
2. Contact: Alice.Wang@bmc.org
RESPECT Plus (Recovery, Empowerment, Social Services, Prenatal care, Education and Community Treatment- Plus)
This is a randomized controlled trial involving postpartum women in treatment for opioid use disorder who received their prenatal care at the RESPECT Clinic. After mothers give birth, dyads are randomized to either the RESPECT-Plus intervention group or Standard of Care group. Those in the intervention group receive services from a Family Specialist, an individual who works in collaboration with the pediatric primary care team and provides child development expertise and family support services. The primary outcomes are to: 1) evaluate an integrated care model, RESPECT-Plus, regarding improving child well-being, safety, and permanency outcomes; and to 2) bring about significant improvements in family functioning aligned with the five protective factors (parental resilience, social connections, knowledge of parenting and child development, concrete support in times of need, social and emotional competence of children) in the Strengthening Families model. This project is funded by the United States Department of Health and Human Services, Agency for Children Youth and Families under the Abandoned Infants Act. The federal grant number is 90CB0186.
1. Status: Actively enrolling
2. Contact: Ruth Rose-Jacobs, rrosejac@bu.edu
3. Gov: NCT02334111
An Observational Study of Hepatitis C Virus in Pregnancy
This is a National Institute of Child Health and Human Development (NICHD) funded multi-site observational study of risk factors for perinatal Hepatitis C virus (HCV) infection. Infants exposed to HCV during the pregnancy are followed closely for HCV infection over the first 18 months of life.
1. Status: Actively enrolling
2. Contact: Vishakha.Sabharwal@bmc.org
3. Gov: NCT01959321
Comparative Safety of Buprenorphine versus Methadone in Pregnancy
This study is funded by the National Institute of Child Health and Human Development (NICHD); Grant No. 1R21HD081271-01 Revised. This is a cohort study using the Massachusetts Medicaid data and supplemental confounder information from a clinical cohort of mother-neonate pairs at Boston Medical Center. This study compares maternal addiction severity upon titration to methadone or buprenorphine in early pregnancy.
1. Status: Actively enrolling
2. Contact: Susan Brogly, PhD, sbrogly@bu.edu
Opioid Use Disorder in Pregnancy and Neonatal Abstinence Syndrome Outcomes
This is a series of retrospective projects related to the Project RESPECT research database. This project is evaluating clinical variables such as maternal opioid agonist therapy, maternal smoking, breastfeeding, and premature birth as contributors to NAS outcomes. Long-term pediatric outcomes, and pain management in opioid-dependent women surrounding C-section delivery are also being examined.
1. Contacts: Elisha.Wachman@bmc.org and Kelley.Saia@bmc.org
Neonatal Abstinence Syndrome Sleep Study
This study investigates how NAS may be related to neonates having difficulty consolidating sleep as part of the syndrome. He is part of a current study to determine if sleep is disturbed in NAS. If we can understand the pathophysiology of the syndrome better, more efficient and safe treatment options may be available in the future. Funding is provided by the Joel Alpert Foundation.
1. Status: Preparing for enrollment
2. Contact: William.Debassio@bmc.org