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

This study has been completed.

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218010
  Purpose

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
Breast Feeding
Opioid-Related Disorders

MedlinePlus related topics:   Breast Feeding   

Drug Information available for:   Methadone    Methadone hydrochloride   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Case Control, Prospective Study
Official Title:   Breastfeeding Among Methadone Maintained Women

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment:   25
Study Start Date:   November 2000
Estimated Study Completion Date:   September 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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    
  More Information


Publications:

Publications indexed to this study:

Study ID Numbers:   NIDA-00495-2, K08-00495-2, DPMC
First Received:   September 16, 2005
Last Updated:   August 2, 2006
ClinicalTrials.gov Identifier:   NCT00218010
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Naphazoline
Oxymetazoline
Methadone
Behavior, Addictive
Guaifenesin
Phenylephrine
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Phenylpropanolamine
Opioid-Related Disorders

Additional relevant MeSH terms:
Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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