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NCT00510016 · ClinicalTrials.gov registry record · Phase 2

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

A Phase 2 study of Neonatal Abstinence Syndrome, sponsored by National Institute on Drug Abuse (NIDA).

Completed
Registry status
Phase 2
Development phase
80
Enrollment target
1
Study location

NCT00510016 is a Phase 2 study of Neonatal Abstinence Syndrome that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 80 participants, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (29% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00510016, a Phase 2 study of Neonatal Abstinence Syndrome, has completed, sponsored by National Institute on Drug Abuse (NIDA).

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG Clonidine HCL

Study Locations (1)

Maryland

  • Johns Hopkins Medical Institutions - Baltimore

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2002-07
Est. Completion 2005-12
Phase Phase 2

What the Registry Record Tells You About NCT00510016

The ClinicalTrials.gov registry entry for NCT00510016 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (29% higher). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Clonidine HCL is the first listed.

NCT00510016 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00510016 about?

NCT00510016 is a clinical study titled "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.

What is the current status of trial NCT00510016?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2002-07. Estimated completion is 2005-12.

What conditions does trial NCT00510016 study?

This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.

What interventions are being tested in trial NCT00510016?

The interventions under investigation include: Clonidine HCL (DRUG).

Who is sponsoring clinical trial NCT00510016?

This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00510016 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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