Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

Neonatal abstinence syndrome is a condition that affects newborns who are exposed to chronic
opioid drugs while they are in a mother's uterus (womb) prior to birth. The current standard
of care treatment includes morphine sulfate. Buprenorphine is a drug used in adults to treat
narcotic dependence and withdrawal, but has not yet been approved for use in newborns as a
treatment alternative for Neonatal Abstinence Syndrome. This investigation is designed to
measure if sublingual (under the tongue) buprenorphine is able to reduce hospital length of
stay and decrease number of days of drug treatment currently required in treatment of NAS.
Another goal will be to understand buprenorphine as a cost effective treatment for NAS.

Inclusion Criteria:

- Infants of corrected gestational age ≥37 weeks

- Chronic opioid exposure in utero

- Signs and symptoms of NAS requiring treatment

- 2 consecutive Finnegan scores ≥8 or any single score ≥12

Exclusion Criteria:

- Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment

- Life-threatening congenital malformations

- Intrauterine growth retardation

- Seizure activity or congenital neurologic abnormalities

- Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment

- Inability of mother's consent due to altered mental status or comorbid psychiatric
disorder

- Neonatal administration of morphine prior to enrollment into study