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...
Date First Received: July 31, 2007
Last Updated: July 31, 2007
Verified by: National Institute on Drug Abuse (NIDA), July 2007
Clinical Trial Phase: Phase 2 | Start Date: July 2002
Overall Status: Completed
Estimated Enrollment: 80
Brief Summary
Official Title: “Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
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 Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Clonidine HCL
- Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
Arms, Groups and Cohorts in this Clinical Trial
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- Length of treatment for neonatal abstinence syndrome
- Time Frame: duration of the treatment
- Time Frame: duration of the treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 14 Days
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
Estelle B Gauda, M.D. Principal Investigator Johns Hopkins Medical Institutions
Related Publications
References
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. No abstract available.
Additional Information
Information obtained from ClinicalTrials.gov on September 07, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00510016
Study ID Number: 1R21DA016288-01A1
ClinicalTrials.gov Identifier: NCT00510016
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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