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Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00521248
First received: August 23, 2007
Last updated: October 20, 2011
Last verified: December 2009
  Purpose

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").


Condition Intervention Phase
Neonatal Abstinence Syndrome
Drug: buprenorphine
Drug: Oral morphine solution
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: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Sublingual Buprenorphine safety and tolerability in the neonate [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Buprenorphine Pharmacokinetics [ Time Frame: Index hospitalization ] [ Designated as safety issue: No ]
  • Efficacy: Length of treatment [ Time Frame: Index hospitalization ] [ Designated as safety issue: No ]
  • Efficacy: Length of hospitalization [ Time Frame: Index hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral morphine solution
Oral morphine solution
Drug: Oral morphine solution
0.4 mg/kg/day morphine every 4 hours
Other Name: morphine
Experimental: Buprenorphine
Sublingual buprenorphine
Drug: buprenorphine
sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
Other Name: Buprenex (buprenorphine)

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521248

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Walter K Kraft, MD, MS Thomas Jefferson University
  More Information

Publications:
Responsible Party: Steve Oversby, NIDA
ClinicalTrials.gov Identifier: NCT00521248     History of Changes
Other Study ID Numbers: R21 DA018207-01, R21DA018207-01, DPMC
Study First Received: August 23, 2007
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Neonatal Abstinence Syndrome
buprenorphine
neonatal
opioid withdrawal

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

ClinicalTrials.gov processed this record on November 24, 2014