Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for
NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic
treatment; those infants born to mothers with co-dependence on an opiate and a
benzodiazepine. Although there are concerns, we anticipate that buprenorphine will be safe in
this population. If it is safe, we can include these infants in the large double blind,
double-dummy buprenorphine and clonidine vs. morphine and clonidine trial. If on the other
hand, these infants have respiratory depression or other adverse events when buprenorphine is
given, it will be important to report this study and caution the use of buprenorphine in
these infants
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Gauda, Estelle B., M.D.
Collaborators:
Johns Hopkins All Children's Hospital Johns Hopkins University
Treatments:
Buprenorphine Buprenorphine, Naloxone Drug Combination Opiate Alkaloids