Alcohol Abuse
Conditions
Brief summary
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.
Interventions
BEHAVIORALMRI 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
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * No current or regular use of prescribed or illicit psychoactive drugs * Free of major health problems (e.g., diabetes, HIV, Parkinson's disease) * Free of neurological or psychiatric disorders * No current drug abuse (e.g., recreational drug use). * Right-hand dominant * Free of claustrophobia * Free of pregnancy or suspected pregnancy * Absent MRI risk factors (e.g., implanted medical device, body mass index \> 35, braces) * Free of medical conditions that render individuals with overly sensitive hearing * Non-naive to alcohol consumption
Exclusion criteria
* Not meeting the inclusion criteria listed above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Alcohol-influenced Behavior | During the course of the MRI session | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Alcohol Group | No Alcohol Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Continuous | 28.2 years STANDARD_DEVIATION 6.8 | 27.75 years STANDARD_DEVIATION 5.74 | 27.96 years STANDARD_DEVIATION 6.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol Group | Changes in Alcohol-influenced Behavior | 1.56 units on a scale | Standard Deviation 0.72 |
| No Alcohol Group | Changes in Alcohol-influenced Behavior | 1.49 units on a scale | Standard Deviation 0.56 |