Skip to main content
OpenTrials
Completed

NCT Number: NCT01945736

Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opiate Withdrawal Syndrome

Age range

91 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

All Children's Hospital, St. Petersburg, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PK Parameters after multiple doses of enteral methadone

    Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period

    • Apparent oral clearance
    • Apparent oral volume of distribution
    • Area under the curve
    • Absorption rate constant

Secondary outcomes

  1. PK of methadone's primary metabolite EDDP

    Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period

  2. PK of R- and S-enantiomers of methadone

    Time frame: Maximum of 7 PK samples based on dosing schedule collectes over a 5 day period

  3. Correlation between plasma and DBS samples

    Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period

  4. Correlation between plasma and scavenge samples

    Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period

  5. Influence of CYP3A4 and CYP3B6 genetic polymorphisms on methadone PK

    Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period

  6. Methadone pharmacodynamics using the WAT-1

    Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period

  7. Adverse events

    Time frame: Study days 1-5 and observational days 6-10

Sponsors and collaborators

Lead sponsor

Kevin Watt

Other

Collaborators

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

Registry information

Official study title

Pharmacokinetics of Multiple Dose Methadone in Children

Acronym: MTH01

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2013
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.