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

This study is currently recruiting participants.
Verified December 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590277
First Posted: May 2, 2012
Last Update Posted: December 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
April 30, 2012
May 2, 2012
December 8, 2017
July 1, 2012
June 30, 2018   (Final data collection date for primary outcome measure)
Automobile driving [ Time Frame: 4 years ]
Driving stimulator
Same as current
Complete list of historical versions of study NCT01590277 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
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 an automobile.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
  • Active Ethanol and Active Iomazenil
  • Active Ethanol and Placebo Iomazenil
  • Placebo Ethanol and Placebo Iomazenil
  • Placebo Ethanol and 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: 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

    Interventions:
    • Drug: Ethanol
    • Drug: 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

    Interventions:
    • Drug: Ethanol
    • Drug: 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

    Interventions:
    • Drug: Ethanol
    • Drug: 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

    Interventions:
    • Drug: Ethanol
    • Drug: Iomazenil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
49
June 30, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females
  • 21-35 years old
  • Medically healthy

Exclusion Criteria:

  • Under the age of 21 or greater than the age 35
  • Positive pregnancy test
  • History of seizures
Sexes Eligible for Study: All
21 Years to 35 Years   (Adult)
Yes
Contact: Christina L Luddy, BS (203) 932-5711 ext 4549 christina.luddy@va.gov
United States
 
 
NCT01590277
CLIN-026-11F
No
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
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Deepak D'Souza, MD MBBS VA Connecticut Healthcare System West Haven Campus, West Haven, CT
VA Office of Research and Development
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP