Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

Neonatal Abstinence Syndrome Clinical Trial

Official title:

A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708707
• Other study ID #: Banner IRB 01-13-0030
• Status: Completed
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: October 31, 2017

Study information

• Verified date: March 2018
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).

Description:

Neonatal abstinence syndrome is a condition that affects newborns who are exposed to chronic opioid drugs while they are in a mother's uterus (womb) prior to birth. The current standard of care treatment includes morphine sulfate. Buprenorphine is a drug used in adults to treat narcotic dependence and withdrawal, but has not yet been approved for use in newborns as a treatment alternative for Neonatal Abstinence Syndrome. This investigation is designed to measure if sublingual (under the tongue) buprenorphine is able to reduce hospital length of stay and decrease number of days of drug treatment currently required in treatment of NAS. Another goal will be to understand buprenorphine as a cost effective treatment for NAS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 31, 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Infants of corrected gestational age =37 weeks

• Chronic opioid exposure in utero

• Signs and symptoms of NAS requiring treatment

• 2 consecutive Finnegan scores =8 or any single score =12

Exclusion Criteria:

• Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment

• Life-threatening congenital malformations

• Intrauterine growth retardation

• Seizure activity or congenital neurologic abnormalities

• Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment

• Inability of mother's consent due to altered mental status or comorbid psychiatric disorder

• Neonatal administration of morphine prior to enrollment into study

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Neonatal Withdrawal Syndrome
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Drug:
• Buprenorphine
The injectable formulation of buprenorphine (Buprenex; Reckitt Benckiser) will be prepared to a final concentration of 0.075 mg/mL in 100% ethanol and simple syrup USP to create a sublingual preparation. Infants initial dose: 15.9 µg/kg per day in 3 divided doses with escalation/weaning based upon standardized scoring of NAS symptoms, using standardized Finnegan scoring Maximum dosage: 60 µg/kg per day Duration: Infants will receive buprenorphine until they are successfully weaned off of opioids and no longer show withdrawal symptoms, evidenced by low Finnegan scores. Mean use in other investigations was 24 days.
• Morphine Sulfate
Oral Morphine Sulfate Dosage: Morphine Sulfate Oral Solution 100mg/5mL Initially dosed at 0.4mg/kg per day in six daily doses Duration of medication administration dependent upon infant symptoms of neonatal withdrawal, with mean duration of use at Banner Good Samaritan Hospital currently averaging 25 days.

Locations

Country	Name	City	State
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	Number of days of hospital admission	Up to hospital discharge, an anticipated average of 4 weeks
Secondary	Number of adverse or serious adverse events		Up to hospital discharge, with length of stay currently averaging approximately 4 weeks
Secondary	Cost efficiency of buprenorphine	Cost of buprenorphine as a product of number of days of administration	At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks
Secondary	Withdrawal symptoms	Finnegan methodology to score withdrawal symptoms every four hours of medication administration	Up to hospital discharge, usually occuring on average 4 weeks
Secondary	Rescue dosage administration	Number of rescue doses of additional medication	Up to hospital discharge, anticipating an average of 4 weeks