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Completed

NCT Number: NCT00510016

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

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.

Completed

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Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Substance-Related Disorders

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287-3200, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Clonidine HCL

Drug

Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm

Other names: Duraclon

Primary outcomes

  1. Length of treatment for neonatal abstinence syndrome

    Time frame: duration of the treatment

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • Johns Hopkins University

Registry information

Official study title

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

Acronym: NAS

Important dates

Study start
2002
Study completion
2005
First posted
Aug 1, 2007
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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