Opiate AddictionNCT02863601
Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics
An observational study of Opiate Addiction and Pregnancy, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Opiate Addiction, Pregnancy
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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) *
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Currently, the standard of care for an opioid-dependent pregnant woman in most institutions is methadone, however, buprenorphine (BUP) is also used for this indication, as it is FDA-approved for opioid addiction although not specifically for pregnant women. There has been increasing evidence that BUP may have comparable efficacy to methadone, and may have fewer severe neonatal complications especially neonatal abstinence syndrome (NAS) and decreased severity of adverse reactions. The dosing of BUP currently is based on studies in men and non-pregnant women (adjusted to the patient's symptomatology using the Clinical Opiate Withdrawal (COW) score, some of which is subjective and some based on objective physiological parameters) and limited animal data that related plasma concentrations of BUP to the degree of saturation of the µ receptor in the brain.
The study team will define the pharmacokinetics and limited pharmacodynamics of BUP in early and late pregnancy and the postpartum period and determine what contributes to the variation in plasma concentrations and response and will also relate plasma concentrations of BUP and its major metabolites to physiologic parameters that can be used to gauge the amount of drug in mother's plasma. It is expected to demonstrate that higher doses of BUP are needed throughout pregnancy and that the dosing regimen can be adjusted using patient covariates and biophysical measurements in addition to the COW scores.
- Conditions
- Opiate Addiction, Pregnancy
- Keywords
- Buprenorphine, Opiate Substitution Treatment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnant | pregnant women prescribed buprenorphine | |
| postpartum | Postpartum women prescribed buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve N. Caritis, MD, University of Pittsburgh
- Investigators
- Steve N Caritis, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863601
- Sponsor's protocol ID
- PRO15120442
- Other IDs
- STUDY19030255
- Status last verified
- May 2024
- First submitted
- 8 Aug 2016
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics
- ClinicalTrials.gov ID
- NCT02863601
- Acronym / sponsor ID
- PRO15120442
- Conditions
- Opiate Addiction, Pregnancy
- Keywords
- Buprenorphine, Opiate Substitution Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently, the standard of care for an opioid-dependent pregnant woman in most institutions is methadone, however, buprenorphine (BUP) is also used for this indication, as it is FDA-approved for opioid addiction although not specifically for pregnant women. There has been increasing evidence that BUP may have comparable efficacy to methadone, and may have fewer severe neonatal complications especially neonatal abstinence syndrome (NAS) and decreased severity of adverse reactions. The dosing of BUP currently is based on studies in men and non-pregnant women (adjusted to the patient's symptomatology using the Clinical Opiate Withdrawal (COW) score, some of which is subjective and some based on objective physiological parameters) and limited animal data that related plasma concentrations of BUP to the degree of saturation of the µ receptor in the brain.
The study team will define the pharmacokinetics and limited pharmacodynamics of BUP in early and late pregnancy and the postpartum period and determine what contributes to the variation in plasma concentrations and response and will also relate plasma concentrations of BUP and its major metabolites to physiologic parameters that can be used to gauge the amount of drug in mother's plasma. It is expected to demonstrate that higher doses of BUP are needed throughout pregnancy and that the dosing regimen can be adjusted using patient covariates and biophysical measurements in addition to the COW scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant | – | –pregnant women prescribed buprenorphine |
| postpartum | – | –Postpartum women prescribed buprenorphine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exposure to BUP (AUC) during pregnancy and the post-partum state
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve N Caritis, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Addiction and Pregnancy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure to BUP (AUC) during pregnancy and the post-partum state (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.