UAB Clinical Site HEAL Neonatal Opioid Withdrawal Pharmacological Treatments

Project Summary
Many infants exposed to opioids antenatally develop Neonatal Opioid Withdrawal Syndrome
(NOWS). The overarching goal of the HEAL Initiative: Neonatal Opioid Withdrawal Syndrome
Pharmacological Treatments Comparative Effectiveness Trial – Clinical Sites (UG1 Clinical Trial
Required) as stated in RFA-HD-21-031 is to design and implement a multi-center, comparative
effectiveness, randomized controlled trial (RCT) to assess the optimal pharmacological treatment
for NOWS. Our clinical site at the University of Alabama at Birmingham (UAB) is a Regional Perinatal
Center with a Comprehensive Addiction in Pregnancy Program (CAPP) that can enroll a large cohort of
infants with NOWS. UAB is also actively enrolling in the UAB Outcomes of Babies with Opioid Exposure
(OBOE) in response to HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium (RFA-
HD-19-025) and the ACT NOW Weaning study. As a center in the NICHD Neonatal Research Network
(NRN) for >25 years, our clinical site has long-standing established productive collaborations with many
other clinical centers. Our center has an excellent track record of enrollment in clinical studies (#1 or 2 in
most NRN trials) with successful follow-up to 2 years of age and beyond, with trained certified examiners
for neurodevelopment. Our investigational pharmacy has worked with us on multiple trials. Therefore,
there is demonstrated adequacy of clinical, administrative and data organizational management facilities.
For this delayed onset clinical trial, the final protocol will be developed in coordination with the other
Clinical Sites and the DCC. We clearly express our intent to participate in a cooperative manner with the
other Clinical Centers, the DCC, the NIH, and the DSMC in all aspects of research in a manner consistent
with the terms of the award. The Specific Aims are:
Specific Aim 1: To develop a protocol in coordination with the other Clinical Sites and the DCC,
to compare morphine, methadone, and buprenorphine, while taking into account non-pharmacologic
factors and adjunct therapies for the management of neonatal opioid withdrawal syndrome.
Specific Aim 2: To recruit and enroll infants with neonatal opioid withdrawal syndrome at our
clinical site in the randomized controlled trial, and measure important short-term outcomes by hospital
discharge.
Specific Aim 3: (A) To determine important neurodevelopmental and other clinical, social, and
environmental outcomes in enrolled infants at two-year follow-up outcomes; and (B) In collaboration
with the other Clinical Sites and the DCC, to disseminate findings of the clinical trial and help develop
evidence-based clinical practice guidelines.

Grant Number: 5UG1HD107580-04
NIH Institute/Center: NIH
Principal Investigator: Namasivayam Ambalavanan