The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
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ClinicalTrials.gov Identifier: NCT01754324 |
Recruitment Status :
Completed
First Posted : December 21, 2012
Last Update Posted : June 13, 2014
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Condition or disease | Intervention/treatment |
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Neonatal Abstinence Syndrome | Drug: Methadone |
Study Type : | Observational |
Actual Enrollment : | 20 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Utility and Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome in Neonates |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Group/Cohort | Intervention/treatment |
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Methadone
All infants requiring pharmacological treatment of their NAS symptoms are treated with a standardized protocol utilizing oral methadone. This treatment protocol has been the standard of care for infants with NAS at our institution for many years. Infants enrolled in this study will have blood samples drawn at predetermined times in order to obtain information regarding the pharmacokinetics of oral methadone in this population.
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Drug: Methadone
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 Name: methadone hydrochloride |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | up to 1 Month (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754324
United States, Ohio | |
The University Hospital | |
Cincinnati, Ohio, United States, 45229 | |
Mercy Hospital Anderson | |
Cincinnati, Ohio, United States, 45255 |
Principal Investigator: | Jason R Wiles, MD | Children's Hospital Medical Center, Cincinnati | |
Principal Investigator: | Henry Akinbi, MD | Children's Hospital Medical Center, Cincinnati | |
Principal Investigator: | Alexander Vinks, PharmD, PhD | Children's Hospital Medical Center, Cincinnati |
Responsible Party: | Jason Wiles, MD, Neonatology Fellow, Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT01754324 |
Other Study ID Numbers: |
CCHMC-PK-1 5T32HD069054 ( U.S. NIH Grant/Contract ) |
First Posted: | December 21, 2012 Key Record Dates |
Last Update Posted: | June 13, 2014 |
Last Verified: | June 2014 |
Neonatal Abstinence Syndrome Pharmacokinetics Methadone Neonate Newborn |
Neonatal Abstinence Syndrome Syndrome Disease Pathologic Processes Infant, Newborn, Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Methadone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |