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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT01590277

Collaborator

(none)

Enrollment

Locations

Arms

120

Anticipated Duration (Months)

24.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual 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 :

Jul 1, 2012

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Automobile driving [4 years]
Driving stimulator

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CERC (VISN1, West Haven, CT)	West Haven	Connecticut	United States	06516
2	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

Principal Investigator: Deepak D'Souza, MD MBBS, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT01590277

Other Study ID Numbers:

CLIN-026-11F

First Posted:

May 2, 2012

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Ethanol

Study Results

No Results Posted as of Oct 20, 2021