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Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

NCT00510016 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-01-11

No results posted yet for this study

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.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DRUG

Clonidine HCL

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

Sponsors & Collaborators

Principal Investigators

  • Estelle B Gauda, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Completion
2005-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00510016 on ClinicalTrials.gov