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Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome (NAS)

Primary Purpose

Neonatal Abstinence Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clonidine HCL
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome focused on measuring infants, opioid withdrawal, abstinence syndrome, methadone, heroin

Eligibility Criteria

undefined - 14 Days (Child)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Johns Hopkins Medical Institutions

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clonidine treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Length of treatment for neonatal abstinence syndrome

Secondary Outcome Measures

Full Information

First Posted
July 31, 2007
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00510016
Brief Title
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
Acronym
NAS
Official Title
Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
Keywords
infants, opioid withdrawal, abstinence syndrome, methadone, heroin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonidine treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clonidine HCL
Other Intervention Name(s)
Duraclon
Intervention Description
Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
Primary Outcome Measure Information:
Title
Length of treatment for neonatal abstinence syndrome
Time Frame
duration of the treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Estelle B Gauda, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-3200
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6597462
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. doi: 10.1016/0165-1781(84)90039-8.
Results Reference
background
PubMed Identifier
6107698
Citation
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.
Results Reference
background
PubMed Identifier
19398463
Citation
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.
Results Reference
derived

Learn more about this trial

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

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