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 range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Breast Feeding trials