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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01590277
First received: April 30, 2012
Last updated: February 11, 2014
Last verified: February 2014

April 30, 2012
February 11, 2014
July 2012
June 2016   (final data collection date for primary outcome measure)
Automobile driving [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • 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 2016
June 2016   (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
Both
21 Years to 35 Years
Yes
Contact: Christina L Luddy, BS (203) 932-5711 ext 4549 christina.luddy@va.gov
Contact: Lawrence V Rispoli, BA (203) 932-5711 ext 4523 Lawrence.Rispoli@va.gov
United States
 
NCT01590277
CLIN-026-11F
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Deepak D'Souza, MD MBBS VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Department of Veterans Affairs
February 2014

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