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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590277
Recruitment Status : Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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 an automobile.

Condition or disease Intervention/treatment Phase
Active Ethanol and Active Iomazenil Active Ethanol and Placebo Iomazenil Placebo Ethanol and Placebo Iomazenil Placebo Ethanol and Active Iomazenil Drug: Ethanol Drug: Iomazenil Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
Actual Study Start Date : July 1, 2012
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: ethanol and iomazenil

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil active ethanol + placebo iomazenil active ethanol + active iomazenil placebo ethanol + active iomazenil

Drug: Ethanol

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil


Drug: Iomazenil

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil


Experimental: placebo ethanol

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil active ethanol + placebo iomazenil active ethanol + active iomazenil placebo ethanol + active iomazenil

Drug: Ethanol

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil


Drug: Iomazenil

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil


Experimental: active iomazenil

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil active ethanol + placebo iomazenil active ethanol + active iomazenil placebo ethanol + active iomazenil

Drug: Ethanol

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil


Drug: Iomazenil

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil


Experimental: placebo iomazenil

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil active ethanol + placebo iomazenil active ethanol + active iomazenil placebo ethanol + active iomazenil

Drug: Ethanol

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil


Drug: Iomazenil

Subjects will receive in a randomized, double-blind, cross-over design, ethanol or placebo and/or iomazenil or placebo.

Potential Randomizations:

placebo ethanol + and placebo iomazenil

active ethanol + placebo iomazenil

active ethanol + active iomazenil

placebo ethanol + active iomazenil





Primary Outcome Measures :
  1. Automobile driving [ Time Frame: 4 years ]
    Driving stimulator



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590277


Locations
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United States, Connecticut
CERC (VISN1, West Haven, CT)
West Haven, Connecticut, United States, 06516
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Deepak D'Souza, MD MBBS VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01590277    
Other Study ID Numbers: CLIN-026-11F
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs