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Alcohol

Active Ethanol and Active Iomazenil for Active Ethanol and Active Iomazenil

Phase 1
Waitlist Available
Led By Deepak D'Souza, MD MBBS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning 20 minutes after the target ethanol dose (brac of 0.1%) has been reached
Awards & highlights

Study Summary

This trialis researching if a drug called iomazenil can reduce the affects of alcohol intoxication and the ability to drive.

Eligible Conditions
  • Active Ethanol and Active Iomazenil
  • Alcoholism
  • Driving Under the Influence (DUI)
  • Iomazenil Study
  • Placebo Effect
  • Alcohol Intoxication

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning 20 minutes after the target ethanol dose (brac of 0.1%) has been reached
This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning 20 minutes after the target ethanol dose (brac of 0.1%) has been reached for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Automobile Driving

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo Ethanol and Active IomazenilExperimental Treatment2 Interventions
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
Group II: Active Ethanol and Placebo IomazenilExperimental Treatment2 Interventions
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
Group III: Active Ethanol and Active IomazenilExperimental Treatment2 Interventions
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
Group IV: Placebo Ethanol and Placebo IomazenilPlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,384 Total Patients Enrolled
Deepak D'Souza, MD MBBSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 Previous Clinical Trials
21 Total Patients Enrolled
Deepak C D'Souza, MD MBBSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for individuals to join this experiment?

"This medical trial is no longer accepting candidates. Initially posted on July 1st 2012 and last updated November 15th 2022, this study has ceased recruitment activities. As an alternative, there are currently one ethanol-based clinical trials recruiting patients, as well as 38 studies involving Iomazenil looking for participants."

Answered by AI

Would I qualify to participate in this experiment?

"This experimental trial is enrolling a cohort of 49 young adults aged 21 to 35 that consume ethanol regularly. To qualify, participants must be male and possess traditional standards of health."

Answered by AI

What is the participant count for this experiment?

"Unfortunately, this medical trial is not currently seeking new participants. It was initially posted on the 1st of July 2012 and last updated on the 15th of November 2022. If you are still in search for a study to participate in, there are one ethanol related research project that is actively recruiting volunteers as well as 38 trials involving Iomazenil."

Answered by AI

What conditions are most commonly addressed with Iomazenil?

"Primarily employed for treating obstructive hypertrophic cardiomyopathy, the use of iomazenil has been extended to communicable diseases, ethylene glycol poisoning, and skin disinfection treatments."

Answered by AI

To what extent could exposure to Iomazenil be hazardous to patient health?

"Our experts at Power determined that Iomazenil's safety merits a score of 2. This is due to the fact this trial falls in Phase 2, which implies some evidence for its security but none for efficacy."

Answered by AI

Are individuals aged 45 and above eligible to partake in this research project?

"As noted in the inclusion criteria, this clinical trial is exclusively available to those between 21 and 35 years old. For persons outside of that age group, 6 trials are catering to people under 18 while 13 studies serve patients over 65."

Answered by AI
~4 spots leftby Apr 2025