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NCT04273776 · ClinicalTrials.gov registry record · Early Phase 1
A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
A Early Phase 1 study of Performance Enhancing Product Use, sponsored by Walter Reed Army Institute of Research (WRAIR).
- Active
- Registry status
- Early Phase 1
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT04273776: Active Early Phase 1 study of Performance Enhancing Product Use, sponsored by Walter Reed Army Institute of Research (WRAIR).
NCT04273776 is a Early Phase 1 study of Performance Enhancing Product Use that is active but no longer recruiting, run by Walter Reed Army Institute of Research (WRAIR). The registered enrollment target is 90 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04273776, a Early Phase 1 study of Performance Enhancing Product Use, is active but no longer recruiting, sponsored by Walter Reed Army Institute of Research (WRAIR).
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.
Primary Outcome
presentation of word lists
Conditions Studied
Interventions
- DRUG Suvorexant 10 mg
- DRUG Placebos
- DRUG Zolpidem
Study Locations (1)
Maryland
- Walter Reed Army Institute of Research - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2025-12-12 |
| Phase | Early Phase 1 |
What the registry record for NCT04273776 still lists
NCT04273776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% higher).
The record links to 1 condition, with Performance Enhancing Product Use appearing as the primary indexed condition, and to 3 interventions - of which Suvorexant 10 mg is the first listed.
NCT04273776 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04273776 about?
NCT04273776 is a clinical study titled "A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study". The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In thi...
What is the current status of trial NCT04273776?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 90 participants. The study started on 2019-12-01. Estimated completion is 2025-12-12.
What conditions does trial NCT04273776 study?
This clinical trial studies the following conditions: Performance Enhancing Product Use.
What interventions are being tested in trial NCT04273776?
The interventions under investigation include: Suvorexant 10 mg (DRUG), Placebos (DRUG), Zolpidem (DRUG).
Who is sponsoring clinical trial NCT04273776?
This trial is sponsored by Walter Reed Army Institute of Research (WRAIR), which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04273776 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
How this trial's enrollment target compares
Where NCT04273776's enrollment target sits among peer trials
90 233rd of 2000 higher than 1,753 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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