drugset / Trial / NCT02249026
Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study
Phase 1/2
Unknown
40 enrolled
Gauda, Estelle B., M.D.
Johns Hopkins All Children's Hospital · collabJohns Hopkins University · collab
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2014-10
- Primary completion
- 2016-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | — | Other |