Program seeks Council approval for a Concept entitled “A comparative effectiveness study of pharmacological therapies in the treatment of neonatal opioid withdrawal syndrome.”
The Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Initiative — part of the Helping to End Addiction Long-Term (HEAL) Initiative — is currently conducting a large-scale clinical trial evaluating different weaning strategies for morphine and methadone when opioid therapy is required for the pharmacological treatment of neonatal opioid withdrawal syndrome. Although morphine and methadone are the most widely used opioids for the treatment of neonatal opioid withdrawal syndrome, buprenorphine is emerging as another potential therapy. Small-scale clinical studies have also suggested that buprenorphine may have clinical benefits over morphine or methadone. However, to date, no large-scale comparative effectiveness study has been performed evaluating the efficacy of buprenorphine versus other opioids in the pharmacological treatment of neonatal opioid withdrawal syndrome, leaving a gap in scientific knowledge that would inform clinical treatment for neonates requiring pharmacological therapy for neonatal opioid withdrawal syndrome.
As such, NICHD, NIDA, and other Institutes propose to leverage existing clinical trial networks to conduct a large-scale comparative effectiveness trial evaluating morphine, methadone, and buprenorphine in the pharmacological management of neonatal opioid withdrawal syndrome. Importantly, both short-term and long-term outcomes for the infant and the caregivers will be assessed and the measurements harmonized with those currently being collected by the ongoing ACT NOW clinical studies. The results from this study will fill a much-needed void in knowledge and greatly impact the clinical care for those infants who require pharmacological therapy for neonatal opioid withdrawal syndrome.
Importantly, this Concept aligns with the NICHD Strategic Plan as well as the objectives of the NIH HEAL Initiative.
Program Contact
Andrew Bremer
Pediatric Growth and Nutrition Branch (PGNB)
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