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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Johns Hopkins University |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00510016 |
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 |
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Neonatal Abstinence Syndrome |
Drug: Clonidine HCL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial |
Enrollment: | 80 |
Study Start Date: | July 2002 |
Study Completion Date: | December 2005 |
Arms | Assigned Interventions |
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Clonidine treatment: Experimental
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.
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Drug: Clonidine HCL
Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
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Ages Eligible for Study: | up to 14 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Medical Institutions | |
Baltimore, Maryland, United States, 21287-3200 |
Principal Investigator: | Estelle B Gauda, M.D. | Johns Hopkins Medical Institutions |
Study ID Numbers: | 1R21DA016288-01A1, 1R21DA016288-01A1 |
Study First Received: | July 31, 2007 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00510016 |
Health Authority: | United States: Food and Drug Administration |
infants opioid withdrawal abstinence syndrome methadone heroin |
Methadone Heroin Mental Disorders Neonatal Abstinence Syndrome |
Clonidine Substance-Related Disorders Disorders of Environmental Origin Infant, Newborn, Diseases |
Sympatholytics Neurotransmitter Agents Disease Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists |
Pharmacologic Actions Pathologic Processes Autonomic Agents Sensory System Agents Therapeutic Uses Syndrome Analgesics Peripheral Nervous System Agents Central Nervous System Agents |