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Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

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ClinicalTrials.gov Identifier: NCT00521248
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : January 12, 2017
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Drug: buprenorphine Drug: Oral morphine solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Study Start Date : April 2004
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Sublingual Buprenorphine safety and tolerability in the neonate [ Time Frame: Index hospitalization ]

Secondary Outcome Measures :
  1. Buprenorphine Pharmacokinetics [ Time Frame: Index hospitalization ]
  2. Efficacy: Length of treatment [ Time Frame: Index hospitalization ]
  3. Efficacy: Length of hospitalization [ Time Frame: Index hospitalization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Walter K Kraft, MD, MS Thomas Jefferson University
Publications of Results:
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Responsible Party: Steve Oversby, NIDA
ClinicalTrials.gov Identifier: NCT00521248    
Other Study ID Numbers: R21DA018207-01 ( U.S. NIH Grant/Contract )
R21DA018207-01 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: December 2009
Keywords provided by National Institute on Drug Abuse (NIDA):
Neonatal Abstinence Syndrome
opioid withdrawal
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists