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NCT01754324 · ClinicalTrials.gov registry record
The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 20
- Enrollment target
NCT01754324: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01754324 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01754324 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Timed blood samples will be collected to estimate pharmacokinetic parameters of oral methadone and its major metabolite EDDP using population pharmacokinetic methods.
Interventions
- DRUG Methadone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-12 |
What the finished NCT01754324 record still lists
NCT01754324 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Methadone is the first listed.
NCT01754324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01754324 about?
NCT01754324 is a clinical study titled "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, muscl...
What is the current status of trial NCT01754324?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2012-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01754324?
The interventions under investigation include: Methadone (DRUG).
Who is sponsoring clinical trial NCT01754324?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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