Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal
Completed
Conditions studied: Opiate Withdrawal Syndrome
In brief
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.
Key facts
- Study ID
- NCT01945736
- Run by
- Kevin Watt
- People needed
- 26
- Starts
- 2014-01-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2018-12-24
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- >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)
You may not qualify if…
- 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
Where it is running
- All Children's Hospital — St. Petersburg, Florida, United States
- Children's Mercy Hospital — Kansas City, Kansas, United States
- C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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