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Completed

NCT Number: NCT01708707

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

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).

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Key information

Conditions

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

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Other names: Oral Morphine Sulfate, Morphine, NDC: 0406-8003-24

Primary outcomes

  1. Hospital length of stay

    Time frame: Up to hospital discharge, an anticipated average of 4 weeks

    Number of days of hospital admission

Secondary outcomes

  1. Number of adverse or serious adverse events

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

  2. Cost efficiency of buprenorphine

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

    Cost of buprenorphine as a product of number of days of administration

  3. Withdrawal symptoms

    Time frame: Up to hospital discharge, usually occuring on average 4 weeks

    Finnegan methodology to score withdrawal symptoms every four hours of medication administration

  4. Rescue dosage administration

    Time frame: Up to hospital discharge, anticipating an average of 4 weeks

    Number of rescue doses of additional medication

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2012
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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