- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06579521
Real-world Experiences of Alcohol and Cognitions Over Time (REACT)
Connecting Alcohol Myopia to Real-World Risk Behaviors Through Cognitive Ecological Momentary Assessment (REACT Phase II: Lab and EMA)
The goal of this clinical trial is to examine how alcohol affects young adults' attention in both laboratory and real-world settings through phone-based cognitive tasks. The main questions this trial is designed to answer are:
- How well do the phone-based cognitive tasks capture alcohol's effects on attention?
- Does the effect of alcohol on attention contribute to risk-taking?
Participants will complete cognitive tasks to assess attention before and after consuming a standard amount of alcohol in the laboratory, and during surveys completed through a phone app for eight weekends.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 21-25
- drink at least 2x/week in the past month
- at least 1 past-month heavy episodic drinking event (4+/5+ standard drinks in a day for females/males)
- have an iPhone
- able to read and understand English
- willing to complete all study procedures
Exclusion Criteria:
- history of alcohol-related treatment or hospitalization
- medical contraindications for alcohol consumption (e.g., contraindicated medication, major psychiatric illness, history of seizure, gastric bypass surgery, cardiac pacemaker, major illness such as liver cirrhosis or hepatitis, past traumatic brain injury, asthma exacerbated by alcohol use, consistent flushing response to alcohol use) or pregnancy, nursing an infant, or plans to become pregnant in the next 8 weeks (i.e., during the EMA monitoring period)
- substantial visual impairment or color blindness (given that cognitive tasks rely on visual cues)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alcohol
|
A standard dose of alcohol will be administered (volume calculated with regard to age, sex assigned at birth, height, and weight) in the form of vodka and combined with mixer at a 1:4 ratio to reach a target breath alcohol concentration of .08%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central Counting Task (phone)
Time Frame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
On a phone, participants will count the number of times a crosshair flashes in the center of the screen.
Each trial will include between 1 and 4 flashes.
There will be 6 trials per block.
After a training block, there will be two blocks administered while sober.
After alcohol consumption, three blocks will be administered on the ascending limb of the BrAC curve.
Number of accurate responses will be evaluated.
|
Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
|
Peripheral Probe Identification Task (phone)
Time Frame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
While counting the number of times a crosshair flashes in the center of a phone screen (central counting task), participants will also be asked to monitor a cued corner (if possible), and shown an array of four colored stimuli.
In each trial, they will be asked to identify whether the color of a probe matches the cued stimulus, with a 50% likelihood of matching.
After a training block, there will be two blocks administered while sober.
After alcohol consumption, three blocks will be administered on the ascending limb of the BrAC curve.
Number of accurate responses will be evaluated.
|
Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
|
Visual Categorization Task (phone)
Time Frame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
On a phone, participants will be presented with one of two visual stimuli (shapes) in a random sequence with equal probability, and asked to categorize each stimuli as quickly as possible (e.g., "Is this a square or circle?") with placement of response buttons (right or left side of screen) randomized.
Each trial consists of a shape categorization.
There are 12 trials per block.
After a training block, there will be two blocks administered while sober.
After alcohol consumption, three blocks will be administered on the ascending limb of the BrAC curve.
Differences in response time will be evaluated for one-back stimuli (change vs. no change) and two-back stimuli (change vs. no change).
|
Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central Counting Task (desktop)
Time Frame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
On a phone, participants will count the number of times a crosshair flashes in the center of the screen.
Each trial will include between 1 and 4 flashes.
A training block of 12 trials will be administered while sober.
After alcohol consumption, two blocks of 120 trials each will be administered on the ascending limb of the BrAC curve.
Number of accurate responses will be evaluated.
|
Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
|
Peripheral Probe Identification Task (desktop)
Time Frame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
While counting the number of times a crosshair flashes in the center of a desktop screen (central counting task), participants will also be asked to monitor a cued corner (if possible), and shown an array of four colored stimuli.
In each trial, they will be asked to identify whether the color of a probe matches the cued stimulus, with a 50% likelihood of matching.
A training block of 12 trials will be administered while sober.
After alcohol consumption, two blocks of 120 trials each will be administered on the ascending limb of the BrAC curve.
Number of accurate responses will be evaluated.
|
Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
|
Auditory Categorization Task (desktop)
Time Frame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
On a desktop, participants will be presented with one of two auditory stimuli (high and low tones) in a random sequence with equal probability, and asked to categorize each stimuli as quickly as possible with placement of response options (shown on right or left side of screen) randomized.
Each trial consists of a shape categorization.
A training block of 12 trials will be administered while sober.
After alcohol consumption, five blocks of 100 trials each will be administered on the ascending limb of the BrAC curve.
Differences in response time will be evaluated for one-back stimuli (change vs. no change) and two-back stimuli (change vs. no change).
|
Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00018677
- R21AA029489 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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