Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

Infants with in utero exposure to opioids often require therapy with morphine for an
extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period
by ~30%. However, infants with both opioid and benzodiazepine exposure were not included in
the trial. This study will test the safety and tolerability of sublingual buprenorphine in
infants with in utero exposure to benzodiazepines or who are breastfeeding.

Inclusion Criteria:

1. ≥ 37 weeks gestation

2. Exposure to opioids in utero

3. Demonstration of signs and symptoms of neonatal abstinence syndrome requiring
treatment

4. Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use
is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by
prescription (as determined by self-report or intake urine) by the mother 30 days
prior to birth.

Exclusion Criteria:

1. Major congenital malformations and/or intrauterine growth retardation defined as
birth weight <2200 gm

2. Medical illness requiring intensification of medical therapy. This includes, but is
not limited to suspected sepsis requiring antibiotic therapy.

3. Hypoglycemia requiring treatment with intravenous dextrose

4. Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)

5. Seizure activity or other neurologic abnormality