- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510016
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome (NAS)
January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)
Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287-3200
- Johns Hopkins Medical Institutions
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of treatment for neonatal abstinence syndrome
Time Frame: duration of the treatment
|
duration of the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Estelle B Gauda, M.D., Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/0165-1781(84)90039-8.
- Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. doi: 10.1016/s0140-6736(80)92295-3. No abstract available.
- 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. doi: 10.1542/peds.2008-0978. Epub 2009 Apr 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
July 31, 2007
First Submitted That Met QC Criteria
July 31, 2007
First Posted (Estimate)
August 1, 2007
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
July 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Disease
- Infant, Newborn, Diseases
- Syndrome
- Neonatal Abstinence Syndrome
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympatholytics
- Clonidine
Other Study ID Numbers
- 1R21DA016288-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Abstinence Syndrome
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Indiana UniversityCompletedNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal Syndrome | Neonatal Opioid WithdrawalUnited States
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Milton S. Hershey Medical CenterNational Institute on Drug Abuse (NIDA)RecruitingNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal SyndromeUnited States
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Spark Biomedical, Inc.Medical University of South Carolina; University of Texas Southwestern Medical...RecruitingNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal SyndromeUnited States
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Thomas Jefferson UniversityChiesi Farmaceutici S.p.A.CompletedNeonatal Abstinence Syndrome | Neonatal Opiate Withdrawal SyndromeUnited States
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PediatrixCompletedNeonatal Abstinence Syndrome | Neonatal Withdrawal SyndromeUnited States
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Tufts Medical CenterCompletedNeonatal Abstinence Syndrome | Neonatal Opioid WithdrawalUnited States
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Tulane UniversityRecruitingNeonatal Abstinence Syndrome | Substance Withdrawal, NeonatalUnited States
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University of VermontNational Institute on Drug Abuse (NIDA); Johns Hopkins University; University... and other collaboratorsCompletedOpioid-use Disorder | Neonatal Abstinence Syndrome | Opioid Withdrawal | Neonatal Opioid Withdrawal SyndromeUnited States
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University of AlbertaAlberta Health services; Alberta Innovates Health Solutions; Covenant HealthRecruitingNeonatal Abstinence SyndromeCanada
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University Hospital, CaenRecruitingNeonatal Abstinence SyndromeFrance
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