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Buprenorphine Treatment of the Neonatal Abstinence Syndrome in Patients With in Utero Benzodiazepine Exposure

This study is currently recruiting participants.
Verified August 2012 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01671410
First received: August 20, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero


Condition Intervention Phase
Neonatal Abstinence Syndrome
 Drug: oral morphine
Drug: sublingual buprenorphine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Opioids and Benzodiazepines

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Length of treatment [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
    This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.


Secondary Outcome Measures:
  • Length of hospitalization [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
    This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine

  • Number of patients requiring supplemental phenobarbital treatment [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
    This endpoint will compare requirement number of patients who require use of supplemental phenobarbital for treatment of NAS

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: Yes ]
    Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.


Other Outcome Measures:
  • Feeding patterns [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
    To compare the feeding patterns, weight gain, and incidence of feeding dysfunction in infants treated with sublingual buprenorphine and oral morphine for NAS


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sublingual buprenorphine
Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
 Drug: sublingual buprenorphine
Other Name: buprenex
Active Comparator: oral morphine
Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
 Drug: oral morphine

Detailed Description:

Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by ~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines. These infants typically have more severe withdraw symptoms and require longer durations of pharmacologic therapy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 37 weeks gestation
  2. Exposure to opioids in utero
  3. Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
  4. Benzodiazepine use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.

Exclusion Criteria:

  1. Major congenital malformations and/or intrauterine growth retardation defined as birth weight <2200 gm
  2. Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
  3. Hypoglycemia requiring treatment with intravenous dextrose
  4. Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
  5. Seizure activity or other neurologic abnormality
  6. hypoglycemia requiring dextrose therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671410

Contacts
Contact: Walter K Kraft, MD 215 955 9077 walter.kraft@jefferson.edu
Contact: Susan Adeniyi-Jones, MD 215 955 2893 sadeniyi@nemours.org

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Walter K Kraft, MD            
Sub-Investigator: Susan Adeniyi-Jones, MD            
Sub-Investigator: Karol Kaltenbach, PhD            
Sub-Investigator: Jay Greenspan, MD            
Sub-Investigator: Heather L Aldridge, CRNP, NNP-BC            
Sub-Investigator: Michelle Epstein, CRNP            
Sub-Investigator: Eileen Skiffington, PNP            
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Walter K Kraft, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01671410     History of Changes
Other Study ID Numbers: 12D.398
Study First Received: August 20, 2012
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Neonatal Abstinence Syndrome
buprenorphine
morphine
benzodiazepine

Additional relevant MeSH terms:
Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Mental Disorders
Buprenorphine
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013