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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN27500021 | Other Identifier | NICHD |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
A total of approximately 24 to 36 infants and children will participate in this study. This study will be done at five medical centers in the United States.
Treatment will be prescribed by the infant or child's doctor and not by the study team.
Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.
Information collected from each subject's routine medical care will include:
Study specific information collected will include:
The duration of the study will be up to 10 days, comprised of a maximum 5 day treatment period a 5 day observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | > or = 90 days to < 2 years on enteral methadone. Dose schedule is per routine medical care. |
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| Cohort 2 | 2 years to < 6 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile. |
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| Cohort 3 | 6 years to < 18 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | To determine the PK of enteral methadone in children > or = 90 days and <18 years treated for opiate withdrawal per routine medical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters after multiple doses of enteral methadone |
| Maximum of 7 PK samples based on dosing schedule collected over a 5 day period |
| Measure | Description | Time Frame |
|---|---|---|
| PK of methadone's primary metabolite EDDP | Maximum of 7 PK samples based on dosing schedule collected over a 5 day period | |
| PK of R- and S-enantiomers of methadone | Maximum of 7 PK samples based on dosing schedule collectes over a 5 day period |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin watt, MD | Duke Medical Center/Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States | ||
| Children's Mercy Hospital |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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The Study team is interested in learning more about how genetic differences in proteins known as cytochrome P450 enzymes effect the breakdown of methadone. The study team will gather leftover blood collected from the infant or child while the infant/child was in this study and send it to a laboratory to test for genetics. There will be no extra blood draws for this part of the study.
The samples for genetic testing will be given a code number and will not be labeled with the infant or child's name or initials, or any other information that could identify the infant or child. Any remaining blood will be destroyed after the genetic laboratory testing is complete.
| Correlation between plasma and DBS samples | Maximum of 7 PK samples based on dosing schedule collected over a 5 day period |
| Correlation between plasma and scavenge samples | Maximum of 7 PK samples based on dosing schedule collected over a 5 day period |
| Influence of CYP3A4 and CYP3B6 genetic polymorphisms on methadone PK | Maximum of 7 PK samples based on dosing schedule collected over a 5 day period |
| Methadone pharmacodynamics using the WAT-1 | Maximum of 7 PK samples based on dosing schedule collected over a 5 day period |
| Adverse events | Study days 1-5 and observational days 6-10 |
| Kansas City |
| Kansas |
| 64108 |
| United States |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |