Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2007

Last Updated Date

July 31, 2007

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Length of treatment for neonatal abstinence syndrome [ Time Frame: duration of the treatment ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Neonatal Abstinence Syndrome

Intervention ^ICMJE

Drug: Clonidine HCL

Study Arms / Comparison Groups

Experimental: 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 14 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00510016

Responsible Party

Study ID Numbers ^ICMJE

1R21DA016288-01A1, 1R21DA016288-01A1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Johns Hopkins University

Investigators ^ICMJE

Principal Investigator:

Estelle B Gauda, M.D.

Johns Hopkins Medical Institutions

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP