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

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.

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