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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)

Tracking Information
First Submitted Date  ICMJE July 31, 2007
First Posted Date  ICMJE August 1, 2007
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2007)
Length of treatment for neonatal abstinence syndrome [ Time Frame: duration of the treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
Official Title  ICMJE Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Neonatal Abstinence Syndrome
Intervention  ICMJE Drug: Clonidine HCL
Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
Other Name: Duraclon
Study Arms  ICMJE 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.
Intervention: Drug: Clonidine HCL
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2007)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00510016
Other Study ID Numbers  ICMJE 1R21DA016288-01A1( U.S. NIH Grant/Contract )
1R21DA016288-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Estelle B Gauda, M.D. Johns Hopkins University
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP