Pregnancy Clinical Trial
Official title:
Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics
Verified date | May 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | May 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Donna DeAngelis | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Terminated |
NCT02537145 -
PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
|