A Study of Breastfeeding in Buprenorphine Maintained Women
|ClinicalTrials.gov Identifier: NCT01806389|
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : March 22, 2017
Last Update Posted : June 15, 2017
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|
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|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|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|
Buprenorphine maintained women at delivery of their infant
- 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
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806389
|Principal Investigator:||Lauren M Jansson, MD||Johns Hopkins University|