CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
Active Ethanol +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01590277
NCT01590277Phase 1Completed
CompareCT.gov

Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans

VA Office of Research and Development·interventional·Posted May 2, 2012·Updated Oct 9, 2024

In Brief

A Phase 1 clinical trial evaluating Active Ethanol, Active Iomazenil, and 1 other intervention for Active Ethanol and Active Iomazenil and 6 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActive Ethanol and Active Iomazenil, Active Ethanol and Placebo Iomazenil, Placebo Ethanol and Active Iomazenil, Placebo Ethanol and Placebo Iomazenil, Alcohol Effect, Driving Under the Influence, Alcohol Impairment
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2, 2012
Enrollment StartDec 14, 2012
Primary CompletionNov 2, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 14.2 years ago

Interventions

Active Ethanoldrug

Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.

Active Iomazenildrug

Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.

Placebodrug

Control: no alcohol, administered for a total of 90 minutes.

Placebodrug

Control: no iomazenil, administered for a total of 10 minutes