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NCT03386591 · ClinicalTrials.gov registry record · Phase 1
Comparison of Naloxone Pharmacokinetics
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03386591 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 30 participants.
The verdict
NCT03386591, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.
Interventions
- DRUG Naloxone
- DEVICE Mucosal atomization device and syringe
- DEVICE Narcan
- DEVICE Intramuscular Auto Injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2018-03-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03386591
The ClinicalTrials.gov registry entry for NCT03386591 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Naloxone is the first listed.
NCT03386591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03386591 about?
NCT03386591 is a clinical study titled "Comparison of Naloxone Pharmacokinetics". Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. M...
What is the current status of trial NCT03386591?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-01-03. Estimated completion is 2018-03-06.
What interventions are being tested in trial NCT03386591?
The interventions under investigation include: Naloxone (DRUG), Mucosal atomization device and syringe (DEVICE), Narcan (DEVICE), Intramuscular Auto Injector (DEVICE).
Who is sponsoring clinical trial NCT03386591?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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