Clinical Trial: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Brief 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").
Detailed Summary:
Sponsor: Thomas Jefferson University
Current Primary Outcome: Sublingual Buprenorphine safety and tolerability in the neonate [ Time Frame: Index hospitalization ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Buprenorphine Pharmacokinetics [ Time Frame: Index hospitalization ]
- Efficacy: Length of treatment [ Time Frame: Index hospitalization ]
- Efficacy: Length of hospitalization [ Time Frame: Index hospitalization ]
Original Secondary Outcome: Same as current
Information By: National Institute on Drug Abuse (NIDA)
Dates:
Date Received: August 23, 2007
Date Started: April 2004
Date Completion:
Last Updated: January 11, 2017
Last Verified: December 2009
