Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)
NCT # 04214834
https://clinicaltrials.gov/ct2/show/NCT04214834
Study Purpose The goal of the ACT NOW Weaning Study is to help clinicians safely reduce doses of morphine or methadone prescribed to infants with Neonatal Opioid Withdrawal Syndrome (NOWS) -- the Weaning Study.
The Trial to Shorten Pharmacologic Treatment of Newborns with Neonatal Opioid Withdrawal Syndrome (The Weaning Study), is designed for newborns who are treated with morphine or methadone for Neonatal Opioid Withdrawal Syndrome in addition to non-pharmacologic interventions. This is a randomized, blinded trial of weaning infants from morphine or methadone by decrements of 10% each day (as commonly used in clinical practice) compared to more rapid weaning of 15% each day. The ACT NOW Weaning clinical trial has enrolled 189 infants across 17 states. The results demonstrated that newborns weaned more rapidly had approximately 3 less days of treatment with opioids compared to infants weaned slower. The Weaning Trial was presented at the Pediatric Academic Society Meeting in Honolulu, Hawaii, 2025.
The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®. Learn more about this aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis here.
List of ACT NOW Weaning Sites and Funded Institutions
Contact information for participating sites can be found here.
| State | Site Name |
| AL | University of Alabama at Birmingham |
| AR | Arkansas Children's Hospital |
| AZ | University of Arizona |
| CA | Loma Linda University Medical Center |
| CA | Sharp Mary Birch |
| FL | Orlando Health |
| IA | University of Iowa |
| LA | Ochsner Baptist Clinical Trials Unit |
| LA | Ochsner Kenner Regional Hospital |
| LA | Tulane University School of Medicine |
| MA | University of Massachusetts Memorial Medical Center |
| MD | MedStar Health |
| MI | Wayne State University School of Medicine |
| MO | Children's Mercy Hospital / Truman |
| MO | Washington University School of Medicine |
| NC | Wake Forest |
| NM | University of New Mexico, Health Sciences Center |
| OH | MetroHealth |
| OH | Nationwide Children's Hospital |
| OH | Ohio State University Hospital |
| RI | Women and Infants Hospital of Rhode Island |
| SD | Sanford Health (Sioux Falls, SD) |
| TN | University of Tennessee Health Science Center |
| WV | West Virginia University Hospital |