Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Status:
Completed
Trial end date:
2019-07-11
Target enrollment:
Participant gender:
Summary
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids
in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment
compared to oral morphine. These results were with an empirically derived dose. This study
will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship
and use a rational approach to define an optimal dose regimen. The clinical trial will be
open label, single arm design with a goal of initial testing of a new dosing regimen.