NCT00521248

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
DRUG	buprenorphine	sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
DRUG	Oral morphine solution	0.4 mg/kg/day morphine every 4 hours

Timeline

• Start date: 2004-04-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-08-27
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States