Aims: More than half of infants exposed to opioids in utero develop neonatal abstinence syndrome (NAS) of severity to require pharmacological therapy. Current treatments are associated with prolonged hospitalization. We sought to optimize the dose of sublingual buprenorphine in the treatment of NAS.
Design: Randomized, Phase 1, open-label, active-control clinical trial comparing sublingual buprenorphine to oral morphine.
Setting: Large, urban, tertiary care hospital.
Participants: Twenty-four term infants requiring pharmacological treatment for NAS.
Measurements: Outcomes were neonatal safety, length of treatment and length of hospitalization.
Findings: Sublingual buprenorphine was safe and effective. Infants treated with buprenorphine had a 23-day length of treatment compared to 38 days for those treated with morphine (P = 0.01), representing a 40% reduction. Length of hospital stay in the buprenorphine group was reduced 24%, from 42 to 32 days (P = 0.05).
Conclusions: Sublingual buprenorphine was safe in NAS, with a substantial efficacy advantage over standard of care therapy with oral morphine.
Trial registration: ClinicalTrials.gov NCT00521248.
© 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.