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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

During the course of the MRI session

Results posted on

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

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

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 session

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Alcohol Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Chester, PhD

Virginia Commonwealth University

Phone: 804-828-7624

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place