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

NCT01590277 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CLIN-026-11F
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 using a driving simulator.

Conditions

Active Ethanol and Active Iomazenil; Active Ethanol and Placebo Iomazenil; Placebo Ethanol and Active Iomazenil; Placebo Ethanol and Placebo Iomazenil; Alcohol Effect; Driving Under the Influence; Alcohol Impairment

Outcome Measures

Primary Outcomes (1)

• Biphasic Ethanol Effects Scale (BAES)

  A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation, and the total score for stimulation also ranges from 0 to 70, with higher scores indicating more stimulation. Timepoints: Administered 160 mins (M160) and 10 mins (M10) prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached (0), and 15 (P15), 70 (P70), 90 (P90), and 150 (P150) minutes after the target ethanol/placebo dose has been reached.

  Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.

Study Arms (4)

Active Ethanol and Active Iomazenil

EXPERIMENTAL

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Drug: Active Ethanol; Drug: Active Iomazenil

Active Ethanol and Placebo Iomazenil

EXPERIMENTAL

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Drug: Active Ethanol; Drug: Placebo

Placebo Ethanol and Active Iomazenil

EXPERIMENTAL

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Drug: Active Iomazenil; Drug: Placebo

Placebo Ethanol and Placebo Iomazenil

PLACEBO COMPARATOR

Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil

Drug: Placebo

Interventions

Active Ethanol DRUG

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.

Active Ethanol and Active Iomazenil; Active Ethanol and Placebo Iomazenil

Active Iomazenil DRUG

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.

Active Ethanol and Active Iomazenil; Placebo Ethanol and Active Iomazenil

Placebo DRUG

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

Placebo Ethanol and Active Iomazenil; Placebo Ethanol and Placebo Iomazenil

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males
• years old
• Medically healthy

You may not qualify if:

• Under the age of 21 or greater than the age 35
• History of seizures

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Driving Under the Influence

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior; Dangerous Behavior

Results Point of Contact

• Title: Deepak Cyril D'Souza, MD
• Organization: VA Connecticut Healthcare System

deepak.dsouza@va.gov

203-932-5711

Study Officials

• Deepak C D'Souza, MD MBBS

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: December 14, 2012
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)