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

VA Office of Research and Development

Status and phase: Completed; Phase 1

Conditions: Alcohol Effect; Active Ethanol and Active Iomazenil; Placebo Ethanol and Active Iomazenil; Alcohol Impairment; Driving Under the Influence; Placebo Ethanol and Placebo Iomazenil; Active Ethanol and Placebo Iomazenil

Treatments: Drug: Placebo; Drug: Active Iomazenil; Drug: Active Ethanol

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01590277

CLIN-026-11F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Male

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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33 participants in 4 patient groups, including a placebo group

Active Ethanol and Active Iomazenil

Experimental group

Description:

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Treatment:

Drug: Active Ethanol

Drug: Active Iomazenil

Active Ethanol and Placebo Iomazenil

Experimental group

Description:

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Treatment:

Drug: Active Ethanol

Drug: Placebo

Drug: Placebo

Placebo Ethanol and Active Iomazenil

Experimental group

Description:

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Treatment:

Drug: Active Iomazenil

Drug: Placebo

Drug: Placebo

Placebo Ethanol and Placebo Iomazenil

Placebo Comparator group

Description:

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Treatment:

Drug: Placebo

Drug: Placebo