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NCT01590277 · ClinicalTrials.gov registry record · Phase 1
Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
A Phase 1 study of Alcohol Effect and Driving Under the Influence, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT01590277: Completed Phase 1 study of Alcohol Effect and Driving Under the Influence, sponsored by VA Office of Research and Development.
NCT01590277 is a Phase 1 study of Alcohol Effect and Driving Under the Influence that has completed, run by VA Office of Research and Development. The registered enrollment target is 33 participants, below the 40-participant average among 4 other Alcohol Effect trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01590277, a Phase 1 study of Alcohol Effect and Driving Under the Influence, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's effects on driving using a driving simulator.
Primary Outcome
A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation,
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Active Ethanol
- DRUG Active Iomazenil
Study Locations (1)
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-12-14 |
| Est. Completion | 2018-11-02 |
| Phase | Phase 1 |
What the finished NCT01590277 record still lists
NCT01590277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 40-participant average among 4 other Alcohol Effect trials with a reported enrollment target (17% lower).
The record links to 7 conditions, with Alcohol Effect appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01590277 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01590277 about?
NCT01590277 is a clinical study titled "Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans". Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's effects on driving using a driving simulator.
What is the current status of trial NCT01590277?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2012-12-14. Estimated completion is 2018-11-02.
What conditions does trial NCT01590277 study?
This clinical trial studies the following conditions: Alcohol Effect, Driving Under the Influence, Alcohol Impairment, Active Ethanol and Active Iomazenil, Active Ethanol and Placebo Iomazenil.
What interventions are being tested in trial NCT01590277?
The interventions under investigation include: Placebo (DRUG), Active Ethanol (DRUG), Active Iomazenil (DRUG).
Who is sponsoring clinical trial NCT01590277?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01590277 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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