Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal
Condition: Opiate Withdrawal Syndrome
MeSH terms: Substance Withdrawal Syndrome
Study type: Observational

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.
    

Detailed description: 
      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:

        -  Participant gender, date of birth, race and ethnicity

        -  Pertinent medical history

        -  Laboratory results (blood count and chemistries) from routine testing ordered by the
           infant or child's regular doctor

        -  Medications of interest the child was given within the 72 hours prior to first dose of
           methadone administered after consent

        -  Time and dose of methadone administered to the child up to 14 days prior to enrollment

      Study specific information collected will include:

        -  Blood sample collection to measure level of methadone

        -  Baseline WAT-1 score (sedation withdrawal assessment of the infant or child used to
           assess symptoms the child/infant may experience when opioid drugs are discontinued).

      The duration of the study will be up to 10 days, comprised of a maximum 5 day treatment
      period a 5 day observation period.
    

Intervention name(s): Methadone
Intervention type(s): Drug
Intervention description(s): To determine the PK of enteral methadone in children > or = 90 days and <18 years treated for opiate withdrawal per routine medical care.
Intervention MeSH terms: Methadone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      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.
    
Keywords: Opiate withdrawal in children