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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: Completed Phase 2 study of Neonatal Abstinence Syndrome, sponsored by National Institute on Drug Abuse (NIDA).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
Interventions
- DRUG Clonidine HCL
Study Locations (1)
Maryland
- Johns Hopkins Medical Institutions - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2002-07 |
| Est. Completion | 2005-12 |
| Phase | Phase 2 |
What the finished NCT00510016 record still lists
NCT00510016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (29% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Neonatal Abstinence Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00510016's enrollment target sits among peer trials
80 5th of 17 higher than 13 of 17 other Neonatal Abstinence Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neonatal Abstinence Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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