Phase 1
N=33
Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
Active Ethanol and Active Iomazenil · Active Ethanol and Placebo Iomazenil · Placebo Ethanol and Active Iomazenil · Placebo Ethanol and Placebo Iomazenil · Alcohol Effect
Bottom Line
View on ClinicalTrials.gov: NCT01590277 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Biphasic Ethanol Effects Scale (BAES) — 3.767; 3.935; 3.813; 3.194 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Active Ethanol (Drug); Active Iomazenil (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biphasic Ethanol Effects Scale (BAES) |
3.767; 3.935; 3.813; 3.194; 4.767; 4.484 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males
- 21-35 years old
- Medically healthy
Exclusion Criteria
- Under the age of 21 or greater than the age 35
- History of seizures
Data sourced from ClinicalTrials.gov (NCT01590277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.