We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521248
First Posted: August 27, 2007
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Buprenorphine Pharmacokinetics [ Time Frame: Index hospitalization ]
  • Efficacy: Length of treatment [ Time Frame: Index hospitalization ]
  • Efficacy: Length of hospitalization [ Time Frame: Index hospitalization ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521248


Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
National Institute on Drug Abuse (NIDA)
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: R21DA018207-01 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: August 23, 2007
First Posted: August 27, 2007
Last Update Posted: January 12, 2017
Last Verified: December 2009

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

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