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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: Completed Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT03386591 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve
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 |
What the finished NCT03386591 record still lists
NCT03386591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Naloxone is the first listed.
NCT03386591 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03386591's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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