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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breastfeeding Among Methadone Maintained Women

Conditions
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Breast Feeding, Opioid-Related Disorders

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Methadone maintained lactating women<br>Methadone maintained women who chose to breastfeed their infants provided breast milk and plasma samples for this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methadone concentrations in breast milk |  | 1-30 days after delivery | 
| methadone concentrations in maternal plasma |  | 1-30 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methadone concentrations in infant plasma |  | 1-30 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methadone, lactation, breastfeeding, maternal opioid dependency