drugset
drugset / Trial / NCT01671410

Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

NCT01671410 ↗

Phase 1 Completed 11 enrolled Thomas Jefferson University
RandomizedParallel-groupOpen-labelTreatment

Summary

The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.

Timeline

Start
2012-08
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 5.3 ug/kg Other
Comparator Morphine Other / unclassified 0.07 mg/kg Oral

Indications

neonatal abstinence syndrome