A Study of Breastfeeding in Buprenorphine Maintained Women

NCT01806389 | Completed Results

• 1 other identifier: NA_00080884
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Dependency

Keywords

Breast milk; Breastfeeding; Lactation; Buprenorphine; Opioid

Outcome Measures

Primary Outcomes (3)

• Maternal Plasma Concentrations of Buprenorphine

  Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30

  Days 2,3,4,14 and 30 after delivery

• Maternal Breast Milk Concentrations of Buprenorphine

  Breast milk will be obtained on these days at the time of peak plasma levels of buprenoprhine

  Days 2,3,4,14 and 30 after delivery

• Infant Plasma Concentrations of Buprenorphine

  Infant plasma concentrations of buprenoprhine obtained on day 14 of life

  Day 14 of life

Study Arms (1)

Buprenorphine

Buprenorphine maintained women at delivery of their infant

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (1)

• Jansson LM, Spencer N, McConnell K, Velez M, Tuten M, Harrow CA, Jones HE, Swortwood MJ, Barnes AJ, Scheidweiler KB, Huestis MA. Maternal Buprenorphine Maintenance and Lactation. J Hum Lact. 2016 Nov;32(4):675-681. doi: 10.1177/0890334416663198. Epub 2016 Sep 26.

  PMID: 27563013 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal urine, plasma and breast milk INnfant plasma

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Limitations and Caveats

Small group size Variable amounts of breast milk received by the majority of the sample Reports of exclusive breastfeeding vs formula supplementation were by maternal report

Results Point of Contact

• Title: Dr. Lauren Jansson
• Organization: Johns Hopkins University School of Medicine

ljansson@jhmi.edu

410-550-5438

Study Officials

• Lauren M Jansson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics Johns Hopkins University School of Medicine

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: March 7, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 15, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share