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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


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


Minimum age: N/A. Maximum age: 14 Days. Gender(s): Both.


- 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


- 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

Page last updated: August 20, 2015

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