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| ID | Type | Description | Link |
|---|---|---|---|
| K01AA026647 | 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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This study examines the genetic factors that impact cognitive processes and behavior after alcohol consumption. Participation in this project will contribute to a better understanding of cognitive factors that influence alcohol misuse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol Group | Active Comparator | Participants who have recently consumed alcohol. |
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| No Alcohol Group | Sham Comparator | Participants who have not recently consumed alcohol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Scanner | Behavioral | Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Alcohol-influenced Behavior | Aggressive behavior (i.e., the average volume of noise blasts selected to be administered to participants' opponents) after recent consumption of an alcoholic beverages (versus without recent consumption of an alcoholic beverages) will be measured using the validated and computerized Taylor Competitive Reaction-Time Task. The Taylor Competitive Reaction-Time Task consists of multiple trials that each assess aggression, via a four-point scale that ranges from 1 (low noise blast volume [low aggression]) to 4 (high noise blast volume [high aggression]). Noise blast settings are averaged to provide a total score ranging from 1 to 4, with higher scores indicating greater aggression. | During the course of the MRI session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Chester, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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The results being reported apply only to Aim 4 of the grant. Aims 1-3 focused on analyzing existing archival genomic data and were covered by another protocol, which was not entered into CT.gov, as those aims did not meet the definition of a clinical trial and were approved under a different IRB protocol number and approval process than Aim 4.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol Group | Participants who have recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain. The results being reported apply only to Aim 4 of the grant. |
| FG001 | No Alcohol Group | Participants who have not recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain. The results being reported apply only to Aim 4 of the grant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol Group | Participants who have recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain. We are reporting the data per sequence. The results being reported apply only to Aim 4 of the grant. The results being reported apply only to Aim 4 of the grant. Aims 1-3 focused on analyzing existing archival genomic data and were covered by another protocol, which was not entered into CT.gov, as those aims did not meet the definition of a clinical trial and were approved under a different IRB protocol number and approval process than Aim 4. All participants only completed one session, but within that one session, they completed the loud noises task two times in a row on the same MRI scan, it was done twice to get a more reliable answer when the two measures were combined. |
| 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 | Changes in Alcohol-influenced Behavior | Aggressive behavior (i.e., the average volume of noise blasts selected to be administered to participants' opponents) after recent consumption of an alcoholic beverages (versus without recent consumption of an alcoholic beverages) will be measured using the validated and computerized Taylor Competitive Reaction-Time Task. The Taylor Competitive Reaction-Time Task consists of multiple trials that each assess aggression, via a four-point scale that ranges from 1 (low noise blast volume [low aggression]) to 4 (high noise blast volume [high aggression]). Noise blast settings are averaged to provide a total score ranging from 1 to 4, with higher scores indicating greater aggression. | The results apply only to Aim 4. Aims 1-3 were covered by another protocol that did not meet the definition of a ct and were approved under a different IRB protocol #. All participants completed only one session, but within that session, they performed the loud noises task twice consecutively on the same MRI scan.It was done twice to get a more reliable answer when the two measures were combined. | Posted | Mean | Standard Deviation | units on a scale | During the course of the MRI session |
Duration of the one-day session, including the MRI scan and the computer tasks. The data was only collected during the one-day session.
Self-report by the participants
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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 Group | Participants who have recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain The results being reported apply only to Aim 4 of the grant. Aims 1-3 focused on analyzing existing archival genomic data and were covered by another protocol, which was not entered into CT.gov, as those aims did not meet the definition of a clinical trial and were approved under a different IRB protocol number and approval process than Aim 4. All participants only completed one session, but within that one session, they completed the loud noises task two times in a row on the same MRI scan, it was done twice to get a more reliable answer when the two measures were combined. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Chester, PhD | Virginia Commonwealth University | 804-828-7624 | dschester@vcu.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 | Aug 24, 2018 | Jun 27, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2022 | Sep 30, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| BG001 | No Alcohol Group | Participants who have not recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain. We are reporting the data per sequence. The results being reported apply only to Aim 4 of the grant. The results being reported apply only to Aim 4 of the grant. Aims 1-3 focused on analyzing existing archival genomic data and were covered by another protocol, which was not entered into CT.gov, as those aims did not meet the definition of a clinical trial and were approved under a different IRB protocol number and approval process than Aim 4. All participants only completed one session, but within that one session, they completed the loud noises task two times in a row on the same MRI scan, it was done twice to get a more reliable answer when the two measures were combined. |
| BG002 | Total | Total of all reporting groups |
| 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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| Region of Enrollment | Number | participants |
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| ID | Title | Description |
|---|
| OG000 | Alcohol Group | Participants who have recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain. We are reporting the data per sequence. The results being reported apply only to Aim 4 of the grant. Aims 1-3 focused on analyzing existing archival genomic data. Aim 4 is the only one that met the definition of clinical trial. Aims 1-3 were covered by another protocol, that was not entered into CT.gov since it did not meet the definition of a clinical trial. |
| OG001 | No Alcohol Group | Participants who have not recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain. Aims 1-3 were covered by another protocol, that was not entered into CT.gov since it did not meet the definition of a clinical trial. We are reporting the data per sequence. The results being reported apply only to Aim 4 of the grant. Aims 1-3 focused on analyzing existing archival genomic data. Aim 4 is the only one that met the definition of clinical trial.. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | No Alcohol Group | Participants who have not recently consumed alcohol. MRI Scanner: Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain The results being reported apply only to Aim 4 of the grant. Aims 1-3 focused on analyzing existing archival genomic data and were covered by another protocol, which was not entered into CT.gov, as those aims did not meet the definition of a clinical trial and were approved under a different IRB protocol number and approval process than Aim 4. All participants only completed one session, but within that one session, they completed the loud noises task two times in a row on the same MRI scan, it was done twice to get a more reliable answer when the two measures were combined. | 0 | 4 | 0 | 4 | 0 | 4 |
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