Status:
COMPLETED
Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Breast Feeding
Opioid-Related Disorders
Eligibility:
FEMALE
18-40 years
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 stud...
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 wh...
Eligibility Criteria
Inclusion
- Generally healthy methadone-maintained women electing to either exclusively breastfeed or bottle-feed their infants for 1 month after delivery
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00218010
Start Date
November 1 2000
End Date
September 1 2005
Last Update
January 12 2017
Active Locations (1)
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1
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823