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Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

NCT02863601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2024-05-07

No results posted yet for this 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.

Conditions

  • Opiate Addiction
  • Pregnancy

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Steve N Caritis, MD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02863601 on ClinicalTrials.gov