Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Phase 1

Completed

• Conditions: Neonatal Abstinence Syndrome
• Interventions: Drug: Oral morphine solution; Drug: buprenorphine

• Registration Number: NCT00521248
• Lead Sponsor: Thomas Jefferson University

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 Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2007-08-23
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-27
• Status Verified: 2009-12
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ≥ 37 weeks gestation
• exposure to opiates in utero
• demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

Exclusion Criteria

• major congenital malformations and/or intrauterine growth retardation
• medical illness requiring intensification of medical therapy
• concomitant benzodiazepine or severe alcohol abuse, self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother during pregnancy,
• concomitant use of CYP 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
• seizure activity or other neurologic abnormality
• breast feeding
• inability of mother to give informed consent due to co-morbid psychiatric diagnosis
• hypoglycemia requiring treatment with intravenous glucose

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral morphine solution	Oral morphine solution	Oral morphine solution
Buprenorphine	buprenorphine	Sublingual buprenorphine

Primary Outcome Measures

Name	Time	Method
Sublingual Buprenorphine safety and tolerability in the neonate	Index hospitalization

Secondary Outcome Measures

Name	Time	Method
Buprenorphine Pharmacokinetics	Index hospitalization
Efficacy: Length of treatment	Index hospitalization
Efficacy: Length of hospitalization	Index hospitalization

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States