N/A
N=14
A Study of Breastfeeding in Buprenorphine Maintained Women
Opioid Dependency
Bottom Line
View on ClinicalTrials.gov: NCT01806389 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Maternal Plasma Concentrations of Buprenorphine — 1.2; 1.7; 2.0; 2.4 ug/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Plasma Concentrations of Buprenorphine |
1.2; 1.7; 2.0; 2.4; 2.2 | — |
| PRIMARY Maternal Breast Milk Concentrations of Buprenorphine |
2.3; 1.5; 1.4; 4.8; 3.3 | — |
| PRIMARY Infant Plasma Concentrations of Buprenorphine |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01806389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.