Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Summary

The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid among infants receiving an opioid (defined as morphine or methadone) as the primary treatment for neonatal opioid withdrawal syndrome (NOWS).

Timeline

Start

2020-09-28

Primary completion

2024-01-31

Completion

2026-06-30

Publications

• Laptook AR, Czynski A, Chahine R, Greenberg RG, Smith PB, Oliveira E, Gabrio J, Eggleston B, Das A, Lee J, Lester B, Clark D, Walsh M, Ko H, Asher CC, Friedman H, Gentle S, Rao K, Katheria A, Benninger K, Jani S, Smith MC, Khan A, Talati A, Lodhi S, Mena F, England A, Parimi P, Kylat R, Harmon H, Mannan J, Howell MP, Wright T, Snowden J; ACT NOW Collaborative. Accelerated Weaning of Opioids to Reduce Pharmacologic Exposure for Neonatal Opioid Withdrawal Syndrome: A Randomized Clinical Trial. J Pediatr. 2026 May;292:114992. doi: 10.1016/j.jpeds.2026.114992. Epub 2026 Jan 17.
• Czynski A, Laptook A, Das A, Smith B, Simon A, Greenberg R, Annett R, Lee J, Snowden J, Pedroza C, Lester B, Eggleston B, Bremer D, McGowan E. Pragmatic, randomized, blinded trial to shorten pharmacologic treatment of newborns with neonatal opioid withdrawal syndrome (NOWS). Trials. 2023 Jul 21;24(1):466. doi: 10.1186/s13063-023-07378-x.

Drugs

Indications