CompletedNot Applicable

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

United States25 participantsStarted 2000-11

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

methadone concentrations in breast milk

Timeframe: 1-30 days after delivery

methadone concentrations in maternal plasma

Timeframe: 1-30 days after delivery

Trial details

NCT IDNCT00218010

SponsorNational Institute on Drug Abuse (NIDA)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2005-08

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