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Real-world Experiences of Alcohol and Cognitions Over Time

NCT ID: NCT06579521

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Alcohol Intoxication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alcohol

Group Type EXPERIMENTAL

Alcohol

Intervention Type OTHER

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%.

Interventions

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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%.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Anna Jaffe

Associate Professor, Department of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna E Jaffe, PhD

Role: CONTACT

Phone: 206-221-0355

Email: [email protected]

Facility Contacts

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Anna E Jaffe, PhD

Role: primary

Other Identifiers

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R21AA029489

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00018677

Identifier Type: -

Identifier Source: org_study_id