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NCT Number: NCT01754324

The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome

The chronic use of opiate medications during pregnancy is a major public health challenge. Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly referred to as neonatal abstinence syndrome (NAS). Signs of NAS may include irritability, high-pitched crying, muscle tightness, seizures, diarrhea, vomiting, poor feeding, and unstable body temperature. Many infants may be treated by supportive (non-pharmacological) therapy by minimizing stimulation, cuddling, responding promptly to hunger cues, and other comfort care. However, some infants continue to show severe symptoms of withdrawal despite these interventions. In these cases, infants may be treated with medications (pharmacological therapy). Although it has been several decades since the first descriptions of NAS, there still remains limited information with regards to the most effective treatment. We hypothesize that medical treatment protocols of NAS with methadone can be optimized by better understanding what the body does to the drug (the population-based pharmacokinetics of methadone).

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Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Substance-Related Disorders

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mercy Hospital Anderson, Cincinnati, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic in utero exposure to opiates
  • Term infant, greater than or equal to 37 weeks gestation
  • Failure of non-pharmacologic treatment of NAS
  • Infant meets criteria for pharmacologic treatment of NAS as determined by physical findings consistent with drug withdrawal and Finnegan scoring system
  • The attending neonatologist chooses to treat the qualifying infant with oral methadone.

Exclusion criteria

  • Prematurity
  • Congenital Abnormalities
  • Acutely ill neonates
  • Confounding medical illness necessitating therapy with opiates other than for NAS
  • Neonates whose only exposure to opiates were narcotics administered during labor
  • Infants who are wards of the state

Treatment and study plan

Methadone

Drug

The starting dose of the protocol is 0.05mg/kg by mouth given every 6 hours and gradually decreased in a stepwise, standardized fashion.

Other names: methadone hydrochloride

Primary outcomes

  1. Methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) blood concentration

    Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).

    Timed blood samples will be collected to estimate pharmacokinetic parameters of oral methadone and its major metabolite EDDP using population pharmacokinetic methods.

Secondary outcomes

  1. Failed Protocol Wean

    Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).

    Blood specimens for the analysis of methadone and EDDP concentrations will be obtained from infants who do not tolerate the standard methadone dosing taper to investigate its utility in identifying rapid metabolizers of methadone.

  2. Number of participants requiring adjunctive pharmacological treatment

    Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).

    This endpoint will look at the number of patients who require supplemental phenobarbital in the treatment of NAS symptoms.

  3. Length of hospitalization

    Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).

    This endpoint will describe the number of days infants were hospitalized for treatment of NAS.

  4. Readmission to the hospital

    Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks) and will complete a follow-up survey up to 2 weeks after hospital discharge.

    This endpoint will describe the number of infants treated for NAS who later developed withdrawal symptoms after discharge that required readmission to the hospital.

  5. Clinical resolution of NAS symptoms

    Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks) and will complete a follow-up survey up to 2 weeks after hospital discharge.

    The length of medical therapy with oral methadone (in days) required to result in the clinical resolution of NAS symptoms will be measured.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

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

Registry information

Official study title

The Utility and Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome in Neonates

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2012
Registry last updated
Jun 13, 2014

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.

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