100 Participants Needed

Alcohol for Cognitive Effects

(REACT Trial)

AE
Overseen ByAnna E Jaffe, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that are not safe to mix with alcohol, you may not be eligible to participate.

What data supports the effectiveness of the drug alcohol for cognitive effects?

Some research suggests that moderate alcohol consumption may benefit cognitive functioning in older adults, potentially reducing the risk of dementia, including Alzheimer's disease.12345

Is alcohol generally safe for human use?

Alcohol (ethanol) can impair cognitive and psychomotor functions, especially at higher doses, affecting attention, memory, and motor skills. Even at lower doses, it can subtly affect learning and memory, and its sedative properties can reduce performance in tasks requiring continuous attention.16789

How does the drug ethanol differ from other treatments for cognitive effects?

Ethanol is unique because, at lower doses, it may enhance cognitive processes, unlike other treatments that typically aim to improve cognition without the risk of impairment. It has a biphasic effect, meaning it can both impair and potentially enhance cognitive functions depending on the dose, which is not a common characteristic of standard cognitive treatments.124810

Eligibility Criteria

This trial is for young adults interested in understanding how alcohol affects their attention. Participants will complete tasks before and after drinking a set amount of alcohol in a lab, and then on their phones over eight weekends.

Inclusion Criteria

Able to read and understand English
Drink at least 2 times per week in the past month
Have had at least 1 past-month heavy episodic drinking event (4+ standard drinks in a day for females, 5+ standard drinks in a day for males)
See 3 more

Exclusion Criteria

History of alcohol-related treatment or hospitalization
Substantial visual impairment or color blindness (given that cognitive tasks rely on visual cues)
I cannot consume alcohol due to health reasons or medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Laboratory Session

Participants complete cognitive tasks before and after consuming alcohol to assess attention and risk-taking behaviors

1 day
1 visit (in-person)

Ecological Momentary Assessment (EMA)

Participants complete phone-based cognitive tasks and surveys over 8 weekends while wearing transdermal alcohol biosensors

8 weeks

Follow-up

Participants return to the lab for a follow-up session involving self-report questions and an interview

1 day
1 visit (in-person)

Treatment Details

Interventions

  • Alcohol
Trial Overview The study tests the impact of alcohol on attention by having participants do cognitive tasks in the lab and through an app. It aims to see if these effects influence risk-taking behavior.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AlcoholExperimental Treatment1 Intervention

Alcohol is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

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Approved in United States as Ethanol for:
  • None (not approved as a therapeutic agent)
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Approved in European Union as Ethanol for:
  • None (not approved as a therapeutic agent)
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Approved in Canada as Ethanol for:
  • None (not approved as a therapeutic agent)
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Approved in Japan as Ethanol for:
  • None (not approved as a therapeutic agent)
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Approved in China as Ethanol for:
  • None (not approved as a therapeutic agent)
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Approved in Switzerland as Ethanol for:
  • None (not approved as a therapeutic agent)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Findings from Research

Low doses of ethanol (0.25 g/kg) can enhance both short-term and long-term memory in fear conditioning tasks, while high doses (1.0 g/kg) impair memory, indicating a biphasic effect of ethanol on cognitive function.
The study found that the effects of ethanol on memory were consistent regardless of the salience of the contextual stimuli, suggesting that ethanol's impact on memory is not influenced by how noticeable the context is.
Acute ethanol has biphasic effects on short- and long-term memory in both foreground and background contextual fear conditioning in C57BL/6 mice.Gulick, D., Gould, TJ.[2019]
Acute ethanol intoxication significantly impairs visual sustained attention in male social drinkers, with performance deteriorating as both the dose of alcohol and the duration of the task increase.
The study found that ethanol affects central cognitive processes, as indicated by changes in event-related potentials (ERPs), particularly delays in N2 and P3 latencies, which corresponded with slower reaction times.
Dose-related effects of ethanol on visual sustained attention and event-related potentials.Rohrbaugh, JW., Stapleton, JM., Parasuraman, R., et al.[2019]
Moderate alcohol consumption (13-52 grams of ethanol per day) is associated with better cognitive performance over an 8-year period in older adults, as shown by higher scores on the Cognitive Abilities Screening Instrument (CASI) among current drinkers compared to past consumers or abstainers.
The study involved 1624 Japanese American adults aged 65 and older, and found that the cognitive benefits of alcohol consumption were consistent across genders, suggesting that further research is needed to explore the underlying mechanisms of this relationship.
Alcohol and cognitive performance: a longitudinal study of older Japanese Americans. The Kame Project.Bond, GE., Burr, RL., McCurry, SM., et al.[2022]

References

Acute ethanol has biphasic effects on short- and long-term memory in both foreground and background contextual fear conditioning in C57BL/6 mice. [2019]
Dose-related effects of ethanol on visual sustained attention and event-related potentials. [2019]
Alcohol and cognitive performance: a longitudinal study of older Japanese Americans. The Kame Project. [2022]
Ethanol and cognition: indirect effects, neurotoxicity and neuroprotection: a review. [2021]
Repeated moderate-dose ethanol bouts impair cognitive function in Wistar rats. [2021]
Therapeutic Applications of Ethanol: A Review. [2020]
Model studies for evaluating the acute neurobehavioral effects of complex hydrocarbon solvents I. Validation of methods with ethanol. [2019]
Alcohol intoxication in humans: effects on vigilance performance. [2013]
Impairment of cognitive and psychomotor function by ethanol in social drinkers. [2013]
Ethanol effects on impulsivity in two mouse strains: similarities to diazepam and ketamine. [2021]
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