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NCT02863601 · ClinicalTrials.gov registry record

Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

A clinical trial, sponsored by University of Pittsburgh.

Completed
Registry status
25
Enrollment target

NCT02863601: Completed study, sponsored by University of Pittsburgh.

NCT02863601 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02863601 has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
25 participants
Enrollment target

Study 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.

Primary Outcome

We will define the pharmacokinetics of BUP in early and late pregnancy and the postpartum period and determine what contributes to the variation in plasma concentrations and response.

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2016-08
Est. Completion 2022-05
University of Pittsburgh

1,238 total trials

What the finished NCT02863601 record still lists

NCT02863601 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02863601 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02863601 about?

NCT02863601 is a clinical study titled "Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics". 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 buprenorphi...

What is the current status of trial NCT02863601?

This trial is currently completed. The enrollment target is 25 participants. The study started on 2016-08. Estimated completion is 2022-05.

Who is sponsoring clinical trial NCT02863601?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02863601, the US trial registry maintained by the National Library of Medicine. NCT02863601 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.