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

Completed

Conditions studied: Breast Feeding, Opioid-Related Disorders

In brief

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.

Key facts

Study ID

NCT00218010

Run by

National Institute on Drug Abuse (NIDA)

People needed

25

Starts

2000-11-01

Expected to finish

2005-09-01

Last updated by the study team

2017-01-12

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Generally healthy methadone-maintained women electing to either exclusively breastfeed or bottle-feed their infants for 1 month after delivery

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University (BPRU) Bayview Campus — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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