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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak C D'Souza, MD MBBS | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States |
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Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: 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
33 participants initiated study procedures beyond screening. Of these 33 participants, 30 completed all four test days (thus receiving all four treatment conditions, one on each of the four test days), 2 participants withdrew from the study after 2 test days (receiving 2 out of the 4 treatment conditions), and 1 participant withdrew after 1 test day (receiving 1 out of the 4 treatment conditions..
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | ARM 1: Active Ethanol and Active 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. ARM 2: Active 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 ARM 3: Placebo Ethanol and Active 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. ARM 4: 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2022 | Sep 18, 2024 |
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| 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. |
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| Placebo | Drug | Control: no alcohol, administered for a total of 90 minutes. |
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| Placebo | Drug | Control: no iomazenil, administered for a total of 10 minutes |
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| Active Ethanol and Placebo Iomazenil |
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| Active Ethanol and Active Iomazenil |
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| Placebo Ethanol and Active Iomazenil |
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| Placebo Ethanol and Placebo Iomazenil |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Participants (N=33) | Baseline demographics for all participants that initiated study procedures beyond screening. Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo on each of 4 separate test days. Potential Randomizations for each test day are: 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. A participant who completes all four test days will receive each of the potential randomizations throughout their study participation. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Ethanol and Active Iomazenil | Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential randomizations for each test day: 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. | 0 | 30 | 0 | 30 | 3 | 30 |
| EG001 | Active Ethanol and Placebo Iomazenil | Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential randomizations for each test day: 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 | 0 | 31 | 0 | 31 | 1 | 31 |
| EG002 | Placebo Ethanol and Active Iomazenil | Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential randomizations for each test day: 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. | 0 | 32 | 0 | 32 | 3 | 32 |
| EG003 | Placebo Ethanol and Placebo Iomazenil | Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential randomizations for each test day: 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 | 0 | 32 | 0 | 32 | 0 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheaded | Nervous system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Stomach Cramps | Gastrointestinal disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepak Cyril D'Souza, MD | VA Connecticut Healthcare System | 203-932-5711 | 2594 | deepak.dsouza@va.gov |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2022 | Sep 18, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000066448 | Driving Under the Influence |
| ID | Term |
|---|---|
| D000066479 | Criminal Behavior |
| D001519 | Behavior |
| D003617 | Dangerous Behavior |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Sedation Effects (Timepoint M10) |
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| Sedation Effects (Timepoint 0) |
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| Sedation Effects (Timepoint P15) |
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| Sedation Effects (Timepoint P70) |
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| Sedation Effects (Timepoint P90) |
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| Sedation Effects (Timepoint P150) |
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| Stimulation Effects (Timepoint M160) |
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| Stimulation Effects (Timepoint M10) |
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| Stimulation Effects (Timepoint 0) |
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| Stimulation Effects (Timepoint P15) |
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| Stimulation Effects (Timepoint P70) |
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| Stimulation Effects (Timepoint P90) |
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| Stimulation Effects (Timepoint P150) |
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