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

NCT01708707 | Completed Phase 2 DMC

• 1 other identifier: Banner IRB 01-13-0030
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neonatal Abstinence Syndrome; Neonatal Withdrawal Syndrome

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  Number of days of hospital admission

  Up to hospital discharge, an anticipated average of 4 weeks

Secondary Outcomes (4)

• Number of adverse or serious adverse events

  Up to hospital discharge, with length of stay currently averaging approximately 4 weeks

• Cost efficiency of buprenorphine

  At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks

• Withdrawal symptoms

  Up to hospital discharge, usually occuring on average 4 weeks

• Rescue dosage administration

  Up to hospital discharge, anticipating an average of 4 weeks

Study Arms (2)

Oral morphine sulfate

ACTIVE COMPARATOR

Oral morphine sulfate 0.4 mg/kg/day morphine every 3-4 hours as needed for Finnegan scores suggestive of Neonatal Abstinence Syndrome Other Name: morphine

Drug: Morphine Sulfate

Buprenorphine

EXPERIMENTAL

Sublingual Buprenorphine 15.9 µg/kg per day in 3 divided doses, titrated up or escalated down based upon standardized scoring for neonatal abstinence syndrome

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

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.

Also known as: Sublingual buprenorphine, Other Name: Buprenex (buprenorphine), NDC Number: 12496-0757-1, Product Code: 12496-0757

Buprenorphine

Morphine Sulfate DRUG

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.

Also known as: Oral Morphine Sulfate, Morphine, NDC: 0406-8003-24

Oral morphine sulfate

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants of corrected gestational age ≥37 weeks
• Chronic opioid exposure in utero
• Signs and symptoms of NAS requiring treatment
• consecutive Finnegan scores ≥8 or any single score ≥12

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatrix: lead

Study Sites (1)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (1)

• Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.

  PMID: 34231914 DERIVED

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Buprenorphine; Morphine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Officials

• Gregory Martin, MD

  Banner University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: October 17, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 31, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-03

Locations

US (1)