Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

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.

Timeline

Start

2018-08-29

Primary completion

2019-07-11

Completion

2019-07-11

Publications

• Results Eudy-Byrne R, Zane N, Adeniyi-Jones SC, Gastonguay MR, Ruiz-Garcia A, Kaushal G, Kraft WK. Pharmacometric dose optimization of buprenorphine in neonatal opioid withdrawal syndrome. Clin Transl Sci. 2021 Nov;14(6):2171-2183. doi: 10.1111/cts.13074. Epub 2021 Sep 16.

Drugs

Indications