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

Completed

• Conditions: Breast Feeding; Opioid-Related Disorders

• Registration Number: NCT00218010
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2005-08
• Study Completion: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Status Verified: 2015-04
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
methadone concentrations in maternal plasma	1-30 days after delivery
methadone concentrations in breast milk	1-30 days after delivery

Secondary Outcome Measures

Name	Time	Method
methadone concentrations in infant plasma	1-30 days after delivery

Trial Locations

Locations (1)

Johns Hopkins University (BPRU) Bayview Campus; 🇺🇸 Baltimore, Maryland, United States