Back to resultsGenetic and Neural Factors in Alcohol-Related Cognition
Primary Purpose
Alcohol Abuse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI Scanner
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Abuse
Eligibility Criteria
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 a neurological or psychiatric disorders
- No current alcohol or drug abuse (e.g., recreational drug use, average alcohol intake in excess of 4 drinks per day).
- 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 inclusion criteria listed above
Sites / Locations
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Alcohol Group
No Alcohol Group
Arm Description
Participants who have recently consumed alcohol.
Participants who have not recently consumed alcohol.
Outcomes
Primary Outcome Measures
Changes in alcohol-influenced behavior
Competitive reaction-time behavior 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. Some outcome measure details are purposely omitted at this time to preserve scientific integrity.
Secondary Outcome Measures
Full Information
NCT ID
NCT03725345
First Posted
October 29, 2018
Last Updated
August 9, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03725345
Brief Title
Genetic and Neural Factors in Alcohol-Related Cognition
Official Title
Genetic and Neural Factors in Alcohol-Related Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is about how genetic and brain factors impact cognitive processes and behavior after alcohol consumption. Participation in this project will contribute to a better understanding of biological factors that influence alcohol misuse. This study will be completed in two laboratory visits.
Detailed Description
Some study details are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
808 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alcohol Group
Arm Type
Active Comparator
Arm Description
Participants who have recently consumed alcohol.
Arm Title
No Alcohol Group
Arm Type
Sham Comparator
Arm Description
Participants who have not recently consumed alcohol.
Intervention Type
Behavioral
Intervention Name(s)
MRI Scanner
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in alcohol-influenced behavior
Description
Competitive reaction-time behavior 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. Some outcome measure details are purposely omitted at this time to preserve scientific integrity.
Time Frame
Approximately 7 days between alcohol consumption.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 a 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 inclusion criteria listed above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Chester, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Chester, PhD
Phone
804-828-7624
Email
dschester@vcu.edu
12. IPD Sharing Statement
Learn more about this trial
Genetic and Neural Factors in Alcohol-Related Cognition
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