Clinical trial NCT06579521: Real-world Experiences of Alcohol and Cognitions Over Time
Official title: Connecting Alcohol Myopia to Real-World Risk Behaviors Through Cognitive Ecological Momentary Assessment (REACT Phase II: Lab and EMA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Intoxication
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The goal of this study is to develop cognitive tasks that assess alcohol-related attentional narrowing (i.e., alcohol myopia) for smartphone-based ecological momentary assessment (EMA). In Phase I, tasks were adapted from computer to smartphone format and refined through interviews with young adults who provided feedback on mock-ups. In Phase II (the current trial), feasibility, acceptability, reliability, and validity of the adapted tasks will be tested in lab and EMA. Young adults who pass an online pre-screening and phone screening will complete an initial lab session involving self-report questionnaires, alcohol consumption (target breath alcohol concentration \[BrAC\] = .08%), and general cognitive and myopia-specific tasks. All participants in Phase II will be assigned to receive a dose of alcohol in the lab session; task performance will be compared within individuals from before to after they are intoxicated. Participants will remain in the lab until their BrAC reduces to a level of .03% and they can pass a field sobriety test. These same participants will then complete EMA while wearing transdermal alcohol biosensors for 8 consecutive weekends, including one morning survey and at least two evening surveys per day. Then, participants will return to the lab for a follow-up session involving self-report questions and an interview eliciting additional feedback. Findings will help to clarify the role of alcohol myopia as a mechanism linking intoxication to real-world risk behaviors.

Eligibility criteria: 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)

Primary outcomes:
measure: Central Counting Task (phone)
timeFrame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
measure: Peripheral Probe Identification Task (phone)
timeFrame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
measure: Visual Categorization Task (phone)
timeFrame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
Secondary outcomes:
measure: Central Counting Task (desktop)
timeFrame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
measure: Peripheral Probe Identification Task (desktop)
timeFrame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
measure: Auditory Categorization Task (desktop)
timeFrame: Baseline and after alcohol consumption in the laboratory (an average of approximately 1 hour after baseline)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: