Opioid DependencyNCT01806389
A Study of Breastfeeding in Buprenorphine Maintained Women
An observational study of Opioid Dependency, run by Johns Hopkins University.
Trial summary
Goals: The overarching goals for this proposed research are to provide pilot data for a study to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine maintenance and to develop guidelines for the practitioner treating buprenorphine maintained women who wish to breastfeed. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Opioid Dependency
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 41 years
- Women only
- No healthy volunteers
- Adult
Study population: Ten buprenorphine maintained women who deliver and infant and desire to breastfeed
Who may be able to join
- Age 18-41 years
- Opioid dependent per DSMIVR criteria, buprenorphine maintained, enrolled in parent study.
- Delivery at 37 weeks of gestation or later
- Breast feeding in the first month of life
Who cannot join
- Concurrent Axis I diagnosis, or the presence of a serious psychiatric illness that would preclude informed consent
- Major congenital malformation or minor congenital malformation that would impair the infant's ability to feed (i.e. Pierre-Robin syndrome, cleft palate)
- Delivery at an outside institution unaffiliated with this protocol
- Failure to leave specimens as per protocol
- Infant medical complications that impair the ability to feed after delivery (i.e. respiratory concerns such as meconium aspiration, perinatal asphyxia, etc. These will be individually determined on a case-by-case basis)
- Any detected maternal medical condition making lactation inadvisable, i.e. newly diagnosed HIV infection or requirement for medication not compatible with breastfeeding.
- Infants with other medical conditions that would make study participation impossible, i.e. nonviable neonates, neonates with uncertain viability.
About this study
Official title: Lactation Among Buprenorphine Maintained Women: A Pilot Study
Goals: The overarching goals for this proposed research are to provide pilot data for a study to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine maintenance and to develop guidelines for the practitioner treating buprenorphine maintained women who wish to breastfeed.
Background: There is an increase in the prevalence of illicit opiate use among women of childbearing age. Recently, a large multisite study has suggested buprenorphine as an alternative to methadone for use in this population. As a consequence, buprenorphine is likely to be delivered to larger populations of pregnant and post-partum women. The population of prenatally opioid-exposed neonates is a particularly vulnerable population. Advances in neuroscience, molecular biology and epigenetics indicate that greater attention should be given to strategies that prevent, reduce, or mitigate the consequences of significant adversity on the developing brain. Breast milk and breastfeeding offer significant health and other benefits that are particularly salient for this group. Today, there is a near complete lack of information regarding the safety of buprenorphine maintenance and lactation, making it unlikely that providers will endorse or mothers will adopt this practice.
Methods: Five pregnant buprenorphine maintained breastfeeding women and their neonates will be enrolled. Subjects will selected by buprenorphine maintenance in the postpartum period and enrollment in a parent protocol and by decision to breast feed their infants. Subject will provide breast milk at times of peak maternal buprenorphine levels on days 2, 3, 4, 14 and 30 after delivery to determine buprenorphine and norbuprenorphine concentrations. Subjects will also provide plasma at times of peak buprenorphine levels for determination of buprenorphine and norbuprenorphine concentrations on the same days. Concentrations of buprenorphine and norbuprenorphine in the plasma of infants will be determined on approximately day 14 of life. The relationship between maternal dose, maternal and infant plasma concentrations, and breast milk concentrations of buprenorphine and norbuprenorphine will be determined, and ingestible infant dose calculated.
Read the detailed description
This study recruits participants from a funded trial evaluating fetal neurobehavior and maternal physiology among a population of opioid dependent and buprenorphine maintained pregnant women. Those women electing to breastfeed will be approached for participation in this study at 36 weeks of gestation.
Study Procedures Study participants will have urine toxicology testing for the following drug classes/cut off values: cocaine/300 ng/mL; methamphetamines/1000ng/mL; methadone/300ng/mL; MDMA/500 ng/mL; MOP/300 ng/mL; oxycodone/100 ng/mL; PCP/25 ng/mL; benzodiazepines/300ng/mL; buprenorphine/10 ng/mL; marijuana/50ng/mL weekly as part of study procedures in addition to weekly random urine toxicology screening provided at CAP for the study period of 36 weeks until delivery. To ensure that participants are not using illicit substances or abusing licit substances and are candidates for the institution and continuation of breastfeeding, subjects will continue to provide urine toxicology testing as above for the period of time from delivery to day 30 postpartum. Subjects noted to be doing so will be discharged from the protocol and referred to their substance abuse treatment counselor for appropriate consequences.
Data collection protocol: Upon delivery, the nursing staff at the hospital of delivery will contact study staff for initiation of study procedures. Women will have plasma and breast milk samples obtained by study personnel on days 2, 3, 4, 14 and 30 at times of peak (2 ½ hours after sublingual dosing) maternal buprenorphine levels. Infant weight will be collected on these days. Days of data collection will be determined by the, 2nd, 3rd, 4th 24 hour periods after birth of the infant. The 14th, and 30th day data collections will occur on the weekday nearest the 24 hour period on those days. Infant NICU Network Neurobehavioral Scale scores on days 3, 14 and 30 and infant NAS scores as below are collected as part of the parent protocol and data abstracted for this protocol.
Maternal plasma: Using 3mL vacutainer green-top collection tubes, 3 cc of blood will be collected via venupuncture by one of two study RNs, one responsible for inpatient specimen collection (i.e. while the mother and infant are hospitalized after delivery) and one responsible for outpatient specimen collection (after hospital discharge). Blood samples will be collected on ice and within two hours, cold centrifuged to harvest the plasma. Plasma will be stored in polypropylene tubes and stored at -20°C. Plasma will be collected at times of peak maternal buprenorphine levels on days 2, 3, 4, 14 (approximately) and 30 (approximately) after infant delivery.
Breast milk: Breast milk samples will be collected after the infant has completed feeding from the same breast via electric pump and consist of approximately 5 cc of breast milk at time of peak maternal buprenorphine levels on days 2,3,4, 14 and 30 after infant delivery. Breast milk will be stored at -20°C within two hours of collection.
Analysis of breast milk and plasma samples: Plasma and breast milk samples will be analyzed by the Chemistry and Drug Metabolism Section of the Intramural Research Program of the National Institute on Drug Abuse, National Institutes of Health in Baltimore, Maryland under the direction of Dr. Marilyn A. Huestis.
Infant plasma: 1cc of infant blood will be taken by heel stick on the weekday nearest day 14 of life. The 14 day blood sample will be coincident with a routine infant blood test (PKU testing) when possible. Blood samples will be collected on ice and within two hours, cold centrifuged to remove plasma. Plasma will be stored in polypropylene tubes and stored at -20°C until analysis.
Other infant data: Infant weight will be obtained at each data collection point (i.e. days 2,3,4, 14 and 30).
Other maternal data: Maternal compliance to drug treatment will be abstracted from daily treatment records. Poor compliance to treatment will be determined on an individual basis via discussion with the subject's counselor, but in general compliance will be determined by attendance to daily therapy at CAP with no unexcused or unexplained absence from treatment in the 30 days subsequent to delivery.
- Conditions
- Opioid Dependency
- Keywords
- Breast milk, Breastfeeding, Lactation, Buprenorphine, Opioid
- Medical subject headings
- Breast Feeding
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 |
|---|---|---|
| Buprenorphine | Buprenorphine maintained women at delivery of their infant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Plasma Concentrations of Buprenorphine
Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30
Measured: Days 2,3,4,14 and 30 after delivery
Maternal Breast Milk Concentrations of Buprenorphine
Breast milk will be obtained on these days at the time of peak plasma levels of buprenoprhine
Measured: Days 2,3,4,14 and 30 after delivery
Infant Plasma Concentrations of Buprenorphine
Infant plasma concentrations of buprenoprhine obtained on day 14 of life
Measured: Day 14 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid DependencyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren M. Jansson, Johns Hopkins University
- Investigators
- Lauren M Jansson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806389
- Sponsor's protocol ID
- NA_00080884
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2013
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jansson LM, Spencer N, McConnell K, Velez M, Tuten M, Harrow CA, Jones HE, Swortwood MJ, Barnes AJ, Scheidweiler KB, Huestis MA. Maternal Buprenorphine Maintenance and Lactation. J Hum Lact. 2016 Nov;32(4):675-681. doi: 10.1177/0890334416663198. Epub 2016 Sep 26.
PubMed 27563013
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactation Among Buprenorphine Maintained Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT01806389
- Acronym / sponsor ID
- NA_00080884
- Conditions
- Opioid Dependency
- Keywords
- Breast milk, Breastfeeding, Lactation, Buprenorphine, Opioid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 22 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Goals: The overarching goals for this proposed research are to provide pilot data for a study to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine maintenance and to develop guidelines for the practitioner treating buprenorphine maintained women who wish to breastfeed.
Background: There is an increase in the prevalence of illicit opiate use among women of childbearing age. Recently, a large multisite study has suggested buprenorphine as an alternative to methadone for use in this population. As a consequence, buprenorphine is likely to be delivered to larger populations of pregnant and post-partum women. The population of prenatally opioid-exposed neonates is a particularly vulnerable population. Advances in neuroscience, molecular biology and epigenetics indicate that greater attention should be given to strategies that prevent, reduce, or mitigate the consequences of significant adversity on the developing brain. Breast milk and breastfeeding offer significant health and other benefits that are particularly salient for this group. Today, there is a near complete lack of information regarding the safety of buprenorphine maintenance and lactation, making it unlikely that providers will endorse or mothers will adopt this practice.
Methods: Five pregnant buprenorphine maintained breastfeeding women and their neonates will be enrolled. Subjects will selected by buprenorphine maintenance in the postpartum period and enrollment in a parent protocol and by decision to breast feed their infants. Subject will provide breast milk at times of peak maternal buprenorphine levels on days 2, 3, 4, 14 and 30 after delivery to determine buprenorphine and norbuprenorphine concentrations. Subjects will also provide plasma at times of peak buprenorphine levels for determination of buprenorphine and norbuprenorphine concentrations on the same days. Concentrations of buprenorphine and norbuprenorphine in the plasma of infants will be determined on approximately day 14 of life. The relationship between maternal dose, maternal and infant plasma concentrations, and breast milk concentrations of buprenorphine and norbuprenorphine will be determined, and ingestible infant dose calculated.
Detailed description
This study recruits participants from a funded trial evaluating fetal neurobehavior and maternal physiology among a population of opioid dependent and buprenorphine maintained pregnant women. Those women electing to breastfeed will be approached for participation in this study at 36 weeks of gestation.
Study Procedures Study participants will have urine toxicology testing for the following drug classes/cut off values: cocaine/300 ng/mL; methamphetamines/1000ng/mL; methadone/300ng/mL; MDMA/500 ng/mL; MOP/300 ng/mL; oxycodone/100 ng/mL; PCP/25 ng/mL; benzodiazepines/300ng/mL; buprenorphine/10 ng/mL; marijuana/50ng/mL weekly as part of study procedures in addition to weekly random urine toxicology screening provided at CAP for the study period of 36 weeks until delivery. To ensure that participants are not using illicit substances or abusing licit substances and are candidates for the institution and continuation of breastfeeding, subjects will continue to provide urine toxicology testing as above for the period of time from delivery to day 30 postpartum. Subjects noted to be doing so will be discharged from the protocol and referred to their substance abuse treatment counselor for appropriate consequences.
Data collection protocol: Upon delivery, the nursing staff at the hospital of delivery will contact study staff for initiation of study procedures. Women will have plasma and breast milk samples obtained by study personnel on days 2, 3, 4, 14 and 30 at times of peak (2 ½ hours after sublingual dosing) maternal buprenorphine levels. Infant weight will be collected on these days. Days of data collection will be determined by the, 2nd, 3rd, 4th 24 hour periods after birth of the infant. The 14th, and 30th day data collections will occur on the weekday nearest the 24 hour period on those days. Infant NICU Network Neurobehavioral Scale scores on days 3, 14 and 30 and infant NAS scores as below are collected as part of the parent protocol and data abstracted for this protocol.
Maternal plasma: Using 3mL vacutainer green-top collection tubes, 3 cc of blood will be collected via venupuncture by one of two study RNs, one responsible for inpatient specimen collection (i.e. while the mother and infant are hospitalized after delivery) and one responsible for outpatient specimen collection (after hospital discharge). Blood samples will be collected on ice and within two hours, cold centrifuged to harvest the plasma. Plasma will be stored in polypropylene tubes and stored at -20°C. Plasma will be collected at times of peak maternal buprenorphine levels on days 2, 3, 4, 14 (approximately) and 30 (approximately) after infant delivery.
Breast milk: Breast milk samples will be collected after the infant has completed feeding from the same breast via electric pump and consist of approximately 5 cc of breast milk at time of peak maternal buprenorphine levels on days 2,3,4, 14 and 30 after infant delivery. Breast milk will be stored at -20°C within two hours of collection.
Analysis of breast milk and plasma samples: Plasma and breast milk samples will be analyzed by the Chemistry and Drug Metabolism Section of the Intramural Research Program of the National Institute on Drug Abuse, National Institutes of Health in Baltimore, Maryland under the direction of Dr. Marilyn A. Huestis.
Infant plasma: 1cc of infant blood will be taken by heel stick on the weekday nearest day 14 of life. The 14 day blood sample will be coincident with a routine infant blood test (PKU testing) when possible. Blood samples will be collected on ice and within two hours, cold centrifuged to remove plasma. Plasma will be stored in polypropylene tubes and stored at -20°C until analysis.
Other infant data: Infant weight will be obtained at each data collection point (i.e. days 2,3,4, 14 and 30).
Other maternal data: Maternal compliance to drug treatment will be abstracted from daily treatment records. Poor compliance to treatment will be determined on an individual basis via discussion with the subject's counselor, but in general compliance will be determined by attendance to daily therapy at CAP with no unexcused or unexplained absence from treatment in the 30 days subsequent to delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | – | –Buprenorphine maintained women at delivery of their infant |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Ten buprenorphine maintained women who deliver and infant and desire to breastfeed
Key inclusion criteria (4 listed)
- Age 18-41 years
- Opioid dependent per DSMIVR criteria, buprenorphine maintained, enrolled in parent study.
- Delivery at 37 weeks of gestation or later
- Breast feeding in the first month of life
Key exclusion criteria (7 listed)
- Concurrent Axis I diagnosis, or the presence of a serious psychiatric illness that would preclude informed consent
- Major congenital malformation or minor congenital malformation that would impair the infant's ability to feed (i.e. Pierre-Robin syndrome, cleft palate)
- Delivery at an outside institution unaffiliated with this protocol
- Failure to leave specimens as per protocol
- Infant medical complications that impair the ability to feed after delivery (i.e. respiratory concerns such as meconium aspiration, perinatal asphyxia, etc. These will be individually determined on a case-by-case basis)
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
Maternal Plasma Concentrations of Buprenorphine
Time frame: Days 2,3,4,14 and 30 after delivery
Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30
Maternal Breast Milk Concentrations of Buprenorphine
Time frame: Days 2,3,4,14 and 30 after delivery
Breast milk will be obtained on these days at the time of peak plasma levels of buprenoprhine
Infant Plasma Concentrations of Buprenorphine
Time frame: Day 14 of life
Infant plasma concentrations of buprenoprhine obtained on day 14 of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27563013Jansson LM, Spencer N, McConnell K, Velez M, Tuten M, Harrow CA, Jones HE, Swortwood MJ, Barnes AJ, Scheidweiler KB, Huestis MA. Maternal Buprenorphine Maintenance and Lactation. J Hum Lact. 2016 Nov;32(4):675-681. doi: 10.1177/0890334416663198. Epub 2016 Sep 26.
- Individual participant dataSharing planned: No
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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.
Lauren M Jansson, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependency, run by Johns Hopkins University.
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 4 inclusion and 7 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maternal Plasma Concentrations of Buprenorphine (time frame: Days 2,3,4,14 and 30 after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01806389, which also lists 1 linked publication.
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 15 Jun 2017.