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Trial record 44 of 332 for:    clonidine

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

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. Identifier: NCT00510016
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : January 11, 2017
Johns Hopkins University
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Drug: Clonidine HCL Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
Study Start Date : July 2002
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Length of treatment for neonatal abstinence syndrome [ Time Frame: duration of the treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

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 identifier (NCT number): NCT00510016

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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
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Principal Investigator: Estelle B Gauda, M.D. Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00510016    
Other Study ID Numbers: 1R21DA016288-01A1 ( U.S. NIH Grant/Contract )
1R21DA016288-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: July 2007
Keywords provided by National Institute on Drug Abuse (NIDA):
opioid withdrawal
abstinence syndrome
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action