Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Drug; Withdrawal Symptoms, Neonatal, Withdrawal, Fetus and Newborn Affected by Other Maternal Medication

In brief

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

Key facts

Study ID

NCT02249026

Run by

Gauda, Estelle B., M.D.

People needed

40

Starts

2014-10-01

Last updated by the study team

2016-05-06

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• All Children's Hopsital — St. Petersburg, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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