Trial Outcomes & Findings for Genetic and Neural Factors in Alcohol-Related Cognition (NCT NCT03725345)
NCT ID: NCT03725345
Last Updated: 2026-01-05
Results Overview
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.
COMPLETED
NA
9 participants
During the course of the MRI session
2026-01-05
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetic and Neural Factors in Alcohol-Related Cognition
Baseline characteristics by cohort
| Measure |
Alcohol Group
n=5 Participants
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.
|
No Alcohol Group
n=4 Participants
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.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=9 Participants
|
4 Participants
n=32 Participants
|
9 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 6.8 • n=9 Participants
|
27.75 years
STANDARD_DEVIATION 5.74 • n=32 Participants
|
27.96 years
STANDARD_DEVIATION 6.27 • n=18 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
7 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
6 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
6 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=9 Participants
|
4 participants
n=32 Participants
|
9 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: During the course of the MRI sessionPopulation: 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.
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.
Outcome measures
| Measure |
Alcohol Group
n=5 Participants
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.
|
No Alcohol Group
n=4 Participants
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..
|
|---|---|---|
|
Changes in Alcohol-influenced Behavior
|
1.56 units on a scale
Standard Deviation .72
|
1.49 units on a scale
Standard Deviation .56
|
Adverse Events
Alcohol Group
No Alcohol Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place