Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
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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 |
|---|---|
|
Active Ethanol and Active Iomazenil Active Ethanol and Placebo Iomazenil Placebo Ethanol and Placebo Iomazenil Placebo Ethanol and Active Iomazenil |
Drug: Ethanol Drug: Iomazenil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans |
- Automobile driving [ Time Frame: 4 years ] [ Designated as safety issue: No ]Driving stimulator
| Estimated Enrollment: | 49 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (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 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 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 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 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Christina L Luddy, BS | (203) 932-5711 ext 4549 | christina.luddy@va.gov |
| Contact: Ashley Schnakenberg, BS | (203) 932-5711 ext 4485 | Ashley.Schnakenberg@va.gov |
| United States, Connecticut | |
| 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 | |
| CERC (VISN1, West Haven, CT) | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Contact: Lawrence Rispoli, BA 203-932-4523 lawrence.rispoli@yale.edu | |
| Principal Investigator: | Deepak D'Souza, MD MBBS | VA Connecticut Healthcare System West Haven Campus, West Haven, CT |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01590277 History of Changes |
| Other Study ID Numbers: | CLIN-026-11F, CSRD CLIN 026 |
| Study First Received: | April 30, 2012 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013