The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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).
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)