Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
Information source: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Abstinence Syndrome
Intervention: Clonidine HCL (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Estelle B Gauda, M.D., Principal Investigator, Affiliation: Johns Hopkins University
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.
Clinical Details
Official title: Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Length of treatment for neonatal abstinence syndrome
Eligibility
Minimum age: N/A.
Maximum age: 14 Days.
Gender(s): Both.
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
Locations and Contacts
Johns Hopkins Medical Institutions, Baltimore, Maryland 21287-3200, United States
Additional Information
Related 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. Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9.
Starting date: July 2002
Last updated: July 31, 2007
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