Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

NCT02863601 | Completed DMC

• 2 other identifiers: PRO15120442STUDY19030255
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Buprenorphine; Opiate Substitution Treatment

Outcome Measures

Primary Outcomes (1)

• Exposure to BUP (AUC) during pregnancy and the post-partum state

  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.

  Between 8 weeks 0/7 days and 20 weeks 6/7 days gestational age; between 21 weeks 0/7 days and 35 weeks 6/7 days gestational age; 4-6 weeks postpartum

Study Arms (2)

pregnant

pregnant women prescribed buprenorphine

postpartum

Postpartum women prescribed buprenorphine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample of pregnant women who are receiving sublingual BUP (subutex) in a supervised hospital or outpatient clinical setting because of their opiate addiction.

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Donna DeAngelis

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous Blood, Hair, Urine, Saliva, Placenta, Umbilical Cord Blood/Tissue, Postpartum Breast Milk

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Steve N Caritis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

US (1)