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

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ClinicalTrials.gov Identifier: NCT00218010
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
, 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.

Condition or disease
Breast Feeding Opioid-Related Disorders

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 Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breastfeeding Among Methadone Maintained Women
Study Start Date : November 2000
Primary Completion Date : August 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Group/Cohort
Methadone maintained lactating women
Methadone maintained women who chose to breastfeed their infants provided breast milk and plasma samples for this study.



Primary Outcome Measures :
  1. methadone concentrations in breast milk [ Time Frame: 1-30 days after delivery ]
  2. methadone concentrations in maternal plasma [ Time Frame: 1-30 days after delivery ]

Secondary Outcome Measures :
  1. methadone concentrations in infant plasma [ Time Frame: 1-30 days after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
lactating women
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218010


Locations
United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Investigators
Principal Investigator: Lauren M. Jansson, MD Johns Hopkins University

Publications:
Responsible Party: , Associate Professor of Pediatrics, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218010     History of Changes
Other Study ID Numbers: NIDA-00495-2
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: April 2015

Keywords provided by , National Institute on Drug Abuse (NIDA):
methadone
lactation
breastfeeding
maternal opioid dependency

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents