Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2

Condition(s) targeted: Breast Feeding; Opioid-Related Disorders

Phase: N/A

Status: Completed

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Lauren M. Jansson, MD, Principal Investigator, Affiliation: Johns Hopkins University

Methadone is a drug that offers significant therapeutic benefits to opiate dependent women who are pregnant. Currently, it is the treatment of choice for this group of people. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.

Official title: Breastfeeding Among Methadone Maintained Women

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

methadone concentrations in breast milk

methadone concentrations in maternal plasma

Secondary outcome: methadone concentrations in infant plasma

Detailed description: Methadone is a drug that is commonly used to treat opiate addiction, usually as part of a detoxification and maintenance program. Methadone offers significant therapeutic benefits to pregnant women who are opiate dependent, and it is currently the treatment of choice for this group of people. In general, breast milk is beneficial for infants. However, there is some concern as to whether it is safe for women who are taking methadone to breastfeed their babies. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior. Participants will be assigned to one of two groups: women taking methadone who will breastfeed their babies or women taking methadone who will bottle-feed their babies. On Days 1, 2, 3, 4, 14, and 30, following infant delivery, plasma will be collected from both groups and breast milk will be collected from the breastfeeding group. These samples will be quantitatively analyzed for methadone. Infants will undergo neurobehavioral assessments on Days 3, 14, and 30, following birth. Rates and severity of neonatal abstinence syndrome will also be evaluated.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Generally healthy methadone-maintained women electing to either exclusively

breastfeed or bottle-feed their infants for 1 month after delivery Exclusion Criteria:

- Relapse to illicit drugs or alcohol at any time during the study

- Positive maternal or infant urine toxicology test at birth

- Serious medical or psychiatric illness requiring medication or medical intervention

- HIV infected

- Currently dependent on alcohol

- Major birth defect in the infant

- Significant medical problems in the infant, including premature birth, sepsis, or

other infections

Johns Hopkins University (BPRU) Bayview Campus, Baltimore, Maryland 21224 6823, United States

Related publications:

Jansson LM, Velez M, Harrow C. Methadone maintenance and lactation: a review of the literature and current management guidelines. J Hum Lact. 2004 Feb;20(1):62-71. Review.

Starting date: November 2000
Last updated: April 15, 2015