Breast Feeding, Opioid-Related Disorders
Conditions
Keywords
methadone, lactation, breastfeeding, maternal opioid dependency
Brief summary
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.
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.
Interventions
None listed
Sponsors
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| methadone concentrations in breast milk | 1-30 days after delivery |
| methadone concentrations in maternal plasma | 1-30 days after delivery |
Secondary
| Measure | Time frame |
|---|---|
| methadone concentrations in infant plasma | 1-30 days after delivery |
Countries
United States
Outcome results
None listed