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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01590277
First received: April 30, 2012
Last updated: May 22, 2017
Last verified: May 2017
  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 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

Study Type: Interventional
Study Design: 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

Further study details as provided by VA Office of Research and Development:

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


Estimated Enrollment: 49
Actual Study Start Date: July 1, 2012
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 2018 (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   (Adult)
Sexes Eligible for Study:   All
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

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
VA Office of Research and Development
Investigators
Principal Investigator: Deepak D'Souza, MD MBBS VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01590277     History of Changes
Other Study ID Numbers: CLIN-026-11F
Study First Received: April 30, 2012
Last Updated: May 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 17, 2017