Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

Completed

Conditions studied: Opiate Addiction, Pregnancy

In brief

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.

Key facts

Study ID

NCT02863601

Run by

University of Pittsburgh

People needed

25

Starts

2016-08-01

Expected to finish

2022-05-01

Last updated by the study team

2024-05-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 - 45 years
• Currently on a stable two, three, four, or five times daily dose of sublingual BUP
• Willingness to participate in at least one pharmacokinetic(PK)/pharmacodynamics study either during pregnancy or in postpartum*
• Gestational age < 19 6/7 weeks *
• Singleton gestation
• Able to give informed consent and undergo study procedures
• Willing to have urine samples screened for the presence of alcohol, barbiturates, opiates, cocaine (or metabolites), benzodiazepines, synthetic opioids and phencyclidine
• Requirement applies only to those subjects in the PK study

You may not qualify if…

• Major fetal anomalies or malformations
• HIV or AIDS
• Comorbid dependence on benzodiazepines or other central nervous system depressants (including anti-seizure medications)
• Taking medication known to interfere with buprenorphine metabolism
• Active or chronic suicidal or homicidal ideation or attempts
• Elevated liver enzymes (AST, alanine aminotransferase (ALT) > 2 times normal) *
• Creatinine > 1.5 mg/dl *
• Delivery at other institution where outcome data or samples cannot be obtained on mother and baby
• Active use of non- prescribed opiates/opioids detected during the urine drug screen performed within 1 week prior to each PK visit *
• Hematocrit <28 *
• Requirement applies only to those subjects in the PK study
• There are several parts to this study and subjects may participate in the PK study and/or one or more procedures other than the PK study. All parts of the study (Parts A-E) are described in the attached protocol.

Where it is running

• Donna DeAngelis — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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