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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Active Ethanol and Active Iomazenil
Active Ethanol and Placebo Iomazenil
Placebo Ethanol and Placebo Iomazenil
Placebo Ethanol and Active Iomazenil
Drug: Ethanol
Drug: Iomazenil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Automobile driving [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Driving stimulator


Estimated Enrollment: 49
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590277

Contacts
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

Locations
United States, Connecticut
CERC (VISN1, West Haven, CT) Recruiting
West Haven, Connecticut, United States, 06516
Contact: Lawrence Rispoli, BA    203-932-4523    lawrence.rispoli@yale.edu   
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Deepak D'Souza, MD MBBS    203-932-5711 ext 2594    Deepak.DSouza@va.gov   
Principal Investigator: Deepak D'Souza, MD MBBS         
Sponsors and Collaborators
Investigators
Principal Investigator: Deepak D'Souza, MD MBBS VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01590277     History of Changes
Other Study ID Numbers: CLIN-026-11F
Study First Received: April 30, 2012
Last Updated: August 5, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014