A Study of Breastfeeding in Buprenorphine Maintained Women

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01806389
First received: February 20, 2013
Last updated: March 12, 2014
Last verified: February 2013
  Purpose

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
Opioid Dependency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lactation Among Buprenorphine Maintained Women: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in maternal plasma concentrations of buprenorphine [ Time Frame: Days 2,3,4,14 and 30 after delivery ] [ Designated as safety issue: No ]
    Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30

  • Change in maternal breast milk concentrations of buprenorphine [ Time Frame: Days 2,3,4,14 and 30 after delivery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Infant plasma will be obtaqined on day 14 of life


Biospecimen Retention:   Samples Without DNA

Maternal urine, plasma and breast milk INnfant plasma


Estimated Enrollment: 5
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Buprenorphine
Buprenorphine maintained women at delivery of their infant

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Five buprenorphine maintained women who deliver and infant and desire to breastfeed

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806389

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

No publications provided

Responsible Party: Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01806389     History of Changes
Other Study ID Numbers: NA_00080884
Study First Received: February 20, 2013
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Breast milk
Breastfeeding
Lactation
Buprenorphine
Opioid

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014