Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kevin Watt; Phillip Brian Smith
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Methadone

Criteria

Inclusion Criteria:

• >90 days - < 18 years of age at the time of first dose of study drug

• Receiving enteral methadone as standard of care

• Signed informed consent/HIPAA documents by the parent/legal guardian and assent (if applicable)

Exclusion Criteria:

• Previous participation in the study

• Subject is receiving ECLS (Extracorporeal Life Support)

• < 36 weeks gestational age at birth for children <1 year of age at time of enrollment

• Any other condition or chronic illness that in the opinion of the Principal

• Investigator makes participation unadvised or unsafe