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Completed

NCT Number: NCT01590277

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

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.

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Key information

Conditions

Active Ethanol and Active Iomazenil Active Ethanol and Placebo Iomazenil Alcohol Effect Alcohol Impairment Behavior Criminal Behavior Dangerous Behavior Driving Under the Influence Placebo Ethanol and Active Iomazenil Placebo Ethanol and Placebo Iomazenil

Age range

21 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Ethanol

Drug

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

Drug

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

Drug

Control: no alcohol, administered for a total of 90 minutes.

Primary outcomes

  1. Biphasic Ethanol Effects Scale (BAES)

    Time frame: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.

    A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation, and the total score for stimulation also ranges from 0 to 70, with higher scores indicating more stimulation.

    Timepoints: Administered 160 mins (M160) and 10 mins (M10) prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached (0), and 15 (P15), 70 (P70), 90 (P90), and 150 (P150) minutes after the target ethanol/placebo dose has been reached.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
May 2, 2012
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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