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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Drug: Active Ethanol
* Drug: Active Iomazenil
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Ethanol and Active Iomazenil<br>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 | Drug: Active Ethanol<br>* 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.<br>Drug: Active Iomazenil<br>* 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.<br>|
| Experimental: Active Ethanol and Placebo Iomazenil<br>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 | Drug: Active Ethanol<br>* 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.<br>Drug: Placebo<br>* Control: no iomazenil, administered for a total of 10 minutes<br>|
| Experimental: Placebo Ethanol and Active Iomazenil<br>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 | Drug: Active Iomazenil<br>* 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.<br>Drug: Placebo<br>* Control: no alcohol, administered for a total of 90 minutes.<br>|
| Placebo Comparator: Placebo Ethanol and Placebo Iomazenil<br>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 | Drug: Placebo<br>* Control: no alcohol, administered for a total of 90 minutes.<br>Drug: Placebo<br>* Control: no iomazenil, administered for a total of 10 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Automobile Driving | The impact of ethanol intoxication upon driving skills such as standard deviation of lateral position (SDLP), will be assessed using a driving simulator. | Beginning 20 minutes after the target ethanol dose (BrAC of 0.1%) has been reached |