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Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal (MTH01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945736
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kevin Watt, Duke University

Tracking Information
First Submitted Date September 16, 2013
First Posted Date September 19, 2013
Last Update Posted Date December 24, 2018
Study Start Date January 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01945736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 16, 2013)
  • PK of methadone's primary metabolite EDDP [ Time Frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period ]
  • 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 ]
  • Correlation between plasma and DBS samples [ Time Frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period ]
  • Correlation between plasma and scavenge samples [ Time Frame: 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 [ Time Frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period ]
  • Methadone pharmacodynamics using the WAT-1 [ Time Frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period ]
  • Adverse events [ Time Frame: Study days 1-5 and observational days 6-10 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal
Official Title Pharmacokinetics of Multiple Dose Methadone in Children
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.

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.
Condition Opiate Withdrawal Syndrome
Intervention Drug: Methadone
To determine the PK of enteral methadone in children > or = 90 days and <18 years treated for opiate withdrawal per routine medical care.
Study Groups/Cohorts
  • Cohort 1
    > or = 90 days to < 2 years on enteral methadone. Dose schedule is per routine medical care.
    Intervention: Drug: Methadone
  • 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.
    Intervention: Drug: Methadone
  • 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.
    Intervention: Drug: Methadone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 4, 2015)
26
Original Estimated Enrollment
 (submitted: September 16, 2013)
36
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 91 Days to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01945736
Other Study ID Numbers Pro00044082
HHSN27500021 ( Other Identifier: NICHD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kevin Watt, Duke University
Study Sponsor Kevin Watt
Collaborators Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Kevin watt, MD Duke Medical Center/Duke Clinical Research Institute
PRS Account Duke University
Verification Date December 2018