Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

— NAS  

Official title:

Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510016
• Other study ID #: 1R21DA016288-01A1
• Secondary ID: 1R21DA016288-01A
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2007
• Last updated: January 10, 2017
• Start date: July 2002
• Est. completion date: December 2005

Study information

• Verified date: July 2007
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Drug:
• Clonidine HCL
Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of treatment for neonatal abstinence syndrome		duration of the treatment