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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01AA024788-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The goal of this research project is to determine the sensitivity of PET radioligands specific for targets in the glutamate system to an alcohol challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol Challenge | Experimental | Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | Alcohol Challenge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol-induced Change in Receptor Availability | The percent change in receptor availability will be measured from the PET data. Since this project is for basic science it is not known whether positive values are better or worse outcome. | Baseline and within 2 hours of challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ansel T Hillmer, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol Challenge | Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once Alcohol: Alcohol Challenge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol Challenge | Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once Alcohol: Alcohol Challenge |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol-induced Change in Receptor Availability | The percent change in receptor availability will be measured from the PET data. Since this project is for basic science it is not known whether positive values are better or worse outcome. | Posted | Mean | Full Range | percentage change of BP_ND | Baseline and within 2 hours of challenge |
|
|
2 Months
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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 | Alcohol Challenge | Alcohol Challenge, oral, targeting BAL of 60 mg/dL, Given once Alcohol: Alcohol Challenge |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ansel Hillmer | Yale University | 203-737-6400 | ansel.hillmer@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2022 | Oct 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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