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Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal

NCT01945736 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2018-12-24

No results posted yet for this study

Summary

The purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults. While this drug is used extensively in infants and children, it has not been extensively studied in this population.

Physicians do not have very much information on how long it takes for methadone to be removed from the blood circulation and passed out of the body. Physicians need more information to guide how much and how often we should give methadone to children/young adults to ensure they get the maximum effect with the minimum amount of drug. During this research study, the study team will collect information about how this drug is processed in infants and children.

Conditions

  • Opiate Withdrawal Syndrome

Interventions

DRUG

Methadone

To determine the PK of enteral methadone in children \> or = 90 days and \<18 years treated for opiate withdrawal per routine medical care.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Kevin Watt

    lead OTHER

Principal Investigators

  • Kevin watt, MD · Duke Medical Center/Duke Clinical Research Institute

Eligibility

Min Age
91 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945736 on ClinicalTrials.gov