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

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.

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

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

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Deepak C D'Souza, MD MBBS · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

35 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-14

Primary Completion

2018-11-02

Completion

2018-11-02

FDA Drug

Yes

Countries

• United States

Study Locations