A Study of Breastfeeding in Buprenorphine Maintained Women
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Lactation Among Buprenorphine Maintained Women: A Pilot Study|
- 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
|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)|
Buprenorphine maintained women at delivery of their infant
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01806389
|Principal Investigator:||Lauren M Jansson, MD||Johns Hopkins University|