Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Newborns ≥ 35 0/7 wks. Gestation undelivered or < 12 hours of age at enrollment and within the 72 hrs. after birth at the time of transfer to ACH for pharmacologic treatment for moderate to severe NAS

• Newborns ≥ 2 kg weight at birth (10th % for a 35 0/7 wk. newborn)

• Informed parental

Exclusion Criteria:

• Newborns <35 0/7 wks. gestation OR older than 72 hrs. of life at time of transfer to ACH for pharmacologic treatment for moderate to severe NAS

• Major congenital anomalies

• Major concomitant medical illness including antibiotic treatment for greater than 3 days

• Any illness that precludes oral or sublingual medication use

• Infants who have received any drug other than "study drug" to treat their NAS

• Infants requiring drug therapy with any high or moderate CYP3A4 inhibitor or inducer (Appendix A)

• Breastfeeding infants.

• Infants in significant pain requiring medication for comfort (for example those with a fracture).