Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521248
• Other study ID #: R21DA018207-01
• Secondary ID: R21DA018207-01DP
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2007
• Last updated: January 11, 2017
• Start date: April 2004
• Est. completion date: January 2010

Study information

• Verified date: December 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Drug:
• buprenorphine
sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
• Oral morphine solution
0.4 mg/kg/day morphine every 4 hours

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kraft WK, Dysart K, Greenspan JS, Gibson E, Kaltenbach K, Ehrlich ME. Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome. Addiction. 2011 Mar;106(3):574-80. doi: 10.1111/j.1360-0443.2010.03170.x. — View Citation

Kraft WK, Gibson E, Dysart K, Damle VS, Larusso JL, Greenspan JS, Moody DE, Kaltenbach K, Ehrlich ME. Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial. Pediatrics. 2008 Sep;122(3):e601-7. doi: 10.1542/peds.2008-05 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sublingual Buprenorphine safety and tolerability in the neonate		Index hospitalization	Yes
Secondary	Buprenorphine Pharmacokinetics		Index hospitalization	No
Secondary	Efficacy: Length of treatment		Index hospitalization	No
Secondary	Efficacy: Length of hospitalization		Index hospitalization	No