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Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

Pregnancy Clinical Trial

Official title:
Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

Clinical Trial Summary

The primary purpose of this study is to determine whether buprenorphine and metabolite exposure (reflected as the dose-adjusted plasma concentration x time curve [AUC]) differs during pregnancy and between pregnancy and the postpartum state.The study will define the pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing based on objective, physiological parameters of satiety. The study will define neonatal exposure to buprenorphine through breast milk.

Clinical Trial Description

Currently, the standard of care for an opioid-dependent pregnant woman in most institutions is methadone, however, buprenorphine (BUP) is also used for this indication, as it is FDA-approved for opioid addiction although not specifically for pregnant women. There has been increasing evidence that BUP may have comparable efficacy to methadone, and may have fewer severe neonatal complications especially neonatal abstinence syndrome (NAS) and decreased severity of adverse reactions. The dosing of BUP currently is based on studies in men and non-pregnant women (adjusted to the patient's symptomatology using the Clinical Opiate Withdrawal (COW) score, some of which is subjective and some based on objective physiological parameters) and limited animal data that related plasma concentrations of BUP to the degree of saturation of the µ receptor in the brain. The study team will define the pharmacokinetics and limited pharmacodynamics of BUP in early and late pregnancy and the postpartum period and determine what contributes to the variation in plasma concentrations and response and will also relate plasma concentrations of BUP and its major metabolites to physiologic parameters that can be used to gauge the amount of drug in mother's plasma. It is expected to demonstrate that higher doses of BUP are needed throughout pregnancy and that the dosing regimen can be adjusted using patient covariates and biophysical measurements in addition to the COW scores. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02863601
Study type Observational
Source University of Pittsburgh
Contact
Status Completed
Phase
Start date August 2016
Completion date May 2022
View Details
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