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

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00510016
First received: July 31, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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 2

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:

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:

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

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 June 18, 2013