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

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: neonatal opium soln.	Phase I

ChemIDplus related topics:

Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

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

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:	30
Study Start Date:	April 2004
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Neonatal opium solution: Active Comparator Neonatal opium soln.	Drug: neonatal opium soln. 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

Contacts and Locations

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

Contacts


Contact: Vidula Damle, MS	215 955 6720	Vidula.damle@jefferson.edu

Contact: Walter K Kraft, MD, MS	215 955 9077	walter.kraft@jefferson.edu

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

Responsible Party:	NIDA ( Steve Oversby )
Study ID Numbers:	R21 DA018207-01
First Received:	August 23, 2007
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00521248
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

Buprenorphine

Mental Disorders

Neonatal Abstinence Syndrome

Substance-Related Disorders

Disorders of Environmental Origin

Infant, Newborn, Diseases

Additional relevant MeSH terms:

Disease

Physiological Effects of Drugs

Narcotic Antagonists

Central Nervous System Depressants

Narcotics

Pharmacologic Actions

Pathologic Processes

Sensory System Agents

Syndrome

Therapeutic Uses

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on September 05, 2008

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