Buprenorphine for the Treatment of Neonatal Abstinence Syndrome - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Thomas Jefferson University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00521248

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oral morphine solution: Active Comparator Oral morphine solution	Drug: Oral morphine solution 0.4 mg/kg/day morphine every 4 hours
Buprenorphine: Experimental Sublingual buprenorphine	Drug: buprenorphine sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms

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

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

Contacts

Contact: Walter K Kraft, MD, MS	215 955 9077	walter.kraft@jefferson.edu
Contact: Kevin Dysart, MD		kcdysart@mac.com

Locations

United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sub-Investigator: Michelle Ehrlich, MD
Sub-Investigator: Eric Gibson, MD
Sub-Investigator: Jay S Greenspan, MD, MBA
Sub-Investigator: Karol Kaltenbach, PhD
Sub-Investigator: Kevin Dysart, MD

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Thomas Jefferson University

Investigators

Principal Investigator:

Walter K Kraft, MD, MS

Thomas Jefferson University

More Information

Publications:

Kraft WK, Gibson E, Dysart K, Damle VS, Larusso JL, Greenspan JS, Moody DE, Kaltenbach K, Ehrlich ME. Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial. Pediatrics. 2008 Sep;122(3):e601-7. Epub 2008 Aug 11.

Responsible Party:	NIDA ( Steve Oversby )
Study ID Numbers:	R21 DA018207-01, R21 DA018207-01, DPMCDA
Study First Received:	August 23, 2007
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00521248 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

Neonatal Abstinence Syndrome
buprenorphine
neonatal
opioid withdrawal

Study placed in the following topic categories:

Morphine
Narcotic Antagonists
Disorders of Environmental Origin
Central Nervous System Depressants
Narcotics
Buprenorphine
Neonatal Abstinence Syndrome

Mental Disorders
Substance-Related Disorders
Infant, Newborn, Diseases
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Morphine
Disease
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Pharmacologic Actions
Buprenorphine
Pathologic Processes
Neonatal Abstinence Syndrome

Mental Disorders
Sensory System Agents
Therapeutic Uses
Syndrome
Substance-Related Disorders
Infant, Newborn, Diseases
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009