A Study of Breastfeeding in Buprenorphine Maintained Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01806389
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : March 22, 2017
Last Update Posted : June 15, 2017
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University

Brief 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.

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.

Condition or disease
Opioid Dependency

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lactation Among Buprenorphine Maintained Women: A Pilot Study
Study Start Date : February 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Buprenorphine maintained women at delivery of their infant

Primary Outcome Measures :
  1. 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

  2. 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

  3. Infant Plasma Concentrations of Buprenorphine [ Time Frame: Day 14 of life ]
    Infant plasma concentrations of buprenoprhine obtained on day 14 of life

Biospecimen Retention:   Samples Without DNA
Maternal urine, plasma and breast milk INnfant plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ten buprenorphine maintained women who deliver and infant and desire to breastfeed

Inclusion Criteria:

  1. Age 18-41 years
  2. Opioid dependent per DSMIVR criteria, buprenorphine maintained, enrolled in parent study.
  3. Delivery at 37 weeks of gestation or later
  4. Breast feeding in the first month of life

Exclusion Criteria:

  1. Concurrent Axis I diagnosis, or the presence of a serious psychiatric illness that would preclude informed consent
  2. Major congenital malformation or minor congenital malformation that would impair the infant's ability to feed (i.e. Pierre-Robin syndrome, cleft palate)
  3. Delivery at an outside institution unaffiliated with this protocol
  4. Failure to leave specimens as per protocol
  5. 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)
  6. Any detected maternal medical condition making lactation inadvisable, i.e. newly diagnosed HIV infection or requirement for medication not compatible with breastfeeding.
  7. Infants with other medical conditions that would make study participation impossible, i.e. nonviable neonates, neonates with uncertain viability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01806389

Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Lauren M Jansson, MD Johns Hopkins University

Publications of Results:
Responsible Party: Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, Johns Hopkins University Identifier: NCT01806389     History of Changes
Other Study ID Numbers: NA_00080884
First Posted: March 7, 2013    Key Record Dates
Results First Posted: March 22, 2017
Last Update Posted: June 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lauren M. Jansson, Johns Hopkins University:
Breast milk

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists