Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome - Full Text View

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome (NAS)

This study has been completed.

First Received on July 31, 2007. No Changes Posted

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Johns Hopkins University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00510016

Purpose

To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.

Condition	Intervention	Phase
Neonatal Abstinence Syndrome	Drug: Clonidine HCL	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Length of treatment for neonatal abstinence syndrome [ Time Frame: duration of the treatment ]

Enrollment:	80
Study Start Date:	July 2002
Study Completion Date:	December 2005

Arms	Assigned Interventions
Experimental: Clonidine treatment Infants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart.	Drug: Clonidine HCL Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm Other Name: Duraclon

Eligibility

Ages Eligible for Study:	up to 14 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

neonates born at gestational age of 35 weeks or greater
neonates aged 0 to 14 days
prenatally exposed to opioids
severe NAS defined as 2 consecutive modified Finnegan Scores (MFS) > or = 9

Exclusion Criteria:

< 35 weeks gestational age
Intrauterine growth retardation defined as <5%tile of gestational age
postnatal treatment with barbiturates or benzodiazepines,
major congenital anomalies
major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
breastfed infants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510016

Locations

United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287-3200

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators

Principal Investigator:

Estelle B Gauda, M.D.

Johns Hopkins Medical Institutions

More Information

Publications:

Hoder EL, Leckman JF, Poulsen J, Caruso KA, Ehrenkranz RA, Kleber HD, Cohen DJ. Clonidine treatment of neonatal narcotic abstinence syndrome. Psychiatry Res. 1984 Nov;13(3):243-51.

Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Agthe AG, Kim GR, Mathias KB, Hendrix CW, Chavez-Valdez R, Jansson L, Lewis TR, Yaster M, Gauda EB. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009 May;123(5):e849-56. Epub 2009 Apr 27.

ClinicalTrials.gov Identifier:	NCT00510016 History of Changes
Other Study ID Numbers:	1R21DA016288-01A1, 1R21DA016288-01A1
Study First Received:	July 31, 2007
Last Updated:	July 31, 2007
Health Authority:	United States: Food and Drug Administration

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

infants
opioid withdrawal
abstinence syndrome
methadone
heroin

Additional relevant MeSH terms:

Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Mental Disorders
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 13, 2012