Clinical Trial: Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Active-Control, Double-Blind, Double-Dummy Clinical Trial Comparing Sublingual Buprenorphine And Morphine Solution For The Treatment Of Neonatal Opioid Abstinence Syndrome
Brief Summary: The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a ~30% reduction length of treatment compared to standard of care morphine. Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed to unequivocally establish the superiority of buprenorphine over morphine. The primary objective of the trial is to compare length of treatment using sublingual buprenorphine or oral morphine solution in the pharmacologic treatment of the NAS.
Detailed Summary:
Sponsor: Thomas Jefferson University
Current Primary Outcome: Length of treatment [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Length of hospitalization [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]This endpoint will compare length of stay (in days) using sublingual buprenorphine or morphine solution.
- Number of patients requiring supplemental phenobarbital treatment. [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]This endpoint will compare requirement number of patients who require use of supplemental phenobarbital.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.
- Buprenorphine blood concentration [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]Heel stick blood will be collected to estimate pharmacokinetic parameters of sublingual buprenorphine using population pharmacokinetic methods.
- Morphine blood concentration [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks. ]Heel stick blood will be collected to estimate pharmacokinetic parameters of oral morphine using population pharmacokinetic methods.
Original Secondary Outcome: Same as current
Information By: Thomas Jefferson University
Dates:
Date Received: October 4, 2011
Date Started: November 2011
Date Completion:
Last Updated: February 3, 2017
Last Verified: February 2017