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

Driving Under the Influence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01590277
• Other study ID #: CLIN-026-11F
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 14, 2012
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Active Ethanol and Active Iomazenil
• Active Ethanol and Placebo Iomazenil
• Alcohol Effect
• Alcohol Impairment
• Driving Under the Influence
• Placebo Ethanol and Active Iomazenil
• Placebo Ethanol and Placebo Iomazenil

Intervention

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.
• 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.
• Placebo
Control: no alcohol, administered for a total of 90 minutes.
• Placebo
Control: no iomazenil, administered for a total of 10 minutes

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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