NCT01590277

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: Male
• Age: 21 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

Alcohol is abused commonly, but there is no antidote for alcohol intoxication the way naltrexone or naloxone is an antidote for opioids. A medication that has the potential to block alcohol actions in the Central Nervous System could act as a unique medication in the treatment of alcohol intoxication and alcoholism. This project is evaluating the benzodiazepine partial inverse agonist, iomazenil, as an agent that could reverse alcohol's effects on subjective intoxication, alcohol's effects on driving using a driving simulator and on measures of electrophysiology in the laboratory in healthy subjects.

Conditions

• Active 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

Interventions

Type	Name	Description
DRUG	Active Ethanol	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.
DRUG	Active Iomazenil	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.
DRUG	Placebo	Control: no alcohol, administered for a total of 90 minutes.
DRUG	Placebo	Control: no iomazenil, administered for a total of 10 minutes

Timeline

• Start date: 2012-12-14
• Primary completion: 2018-11-02
• Completion: 2018-11-02
• First posted: 2012-05-02
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study