Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Neonatal Abstinence Syndrome
Interventions
DRUG

sublingual buprenorphine

Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose

DRUG

oral morphine

Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours

Trial Locations (1)

19107

Thomas Jefferson University Hosptial, Philadelphia

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Thomas Jefferson University

OTHER

NCT01452789 - Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome | Biotech Hunter | Biotech Hunter