Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
NCT ID: NCT01590277
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2012-12-14
2018-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Active Ethanol and Active Iomazenil
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
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.
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.
Active Ethanol and Placebo Iomazenil
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
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.
Placebo
Control: no iomazenil, administered for a total of 10 minutes
Placebo Ethanol and Active Iomazenil
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
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.
Placebo
Control: no alcohol, administered for a total of 90 minutes.
Placebo Ethanol and Placebo Iomazenil
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
Placebo
Control: no alcohol, administered for a total of 90 minutes.
Placebo
Control: no iomazenil, administered for a total of 10 minutes
Interventions
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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.
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.
Placebo
Control: no alcohol, administered for a total of 90 minutes.
Placebo
Control: no iomazenil, administered for a total of 10 minutes
Eligibility Criteria
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Inclusion Criteria
* 21-35 years old
* Medically healthy
Exclusion Criteria
* History of seizures
21 Years
35 Years
MALE
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Deepak C D'Souza, MD MBBS
Role: PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Locations
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VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLIN-026-11F
Identifier Type: -
Identifier Source: org_study_id
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