Clinical trial

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

Name

CLIN-026-11F

Description

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 using a driving simulator.

Trial arms

Trial start

2012-12-14

Estimated PCD

2022-06-30

Trial end

2023-06-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Active Ethanol

Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.

Arms:

Active Ethanol and Active Iomazenil, Active Ethanol and Placebo Iomazenil

Active Iomazenil

Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.

Arms:

Active Ethanol and Active Iomazenil, Placebo Ethanol and Active Iomazenil

Placebo

Control: no alcohol, administered for a total of 90 minutes.

Arms:

Placebo Ethanol and Active Iomazenil, Placebo Ethanol and Placebo Iomazenil

Placebo

Control: no iomazenil, administered for a total of 10 minutes

Arms:

Active Ethanol and Placebo Iomazenil, Placebo Ethanol and Placebo Iomazenil

Size

Primary endpoint

Automobile Driving

Beginning 20 minutes after the target ethanol dose (BrAC of 0.1%) has been reached

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

Updated at

2023-06-13

1 organization

2 products

1 drug

6 indications

Organization

VA Office of Research and Development

Product

Active Ethanol

Indication

Ethanol and Iomazenil