Alcohol for Cognitive Effects

(REACT Trial)

Overseen By Anna E Jaffe, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Contraindicated medication

Disqualifiers: Alcohol treatment, Major psychiatric illness, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how alcohol (also known as ethanol or ethyl alcohol) affects attention in young adults, both in a lab setting and in real life. Participants will perform attention tasks before and after consuming a standard amount of alcohol and will complete surveys over several weekends using an app. The researchers aim to determine if these tasks can effectively measure alcohol's effects on attention and whether these effects lead to risk-taking behavior. The trial suits individuals aged 21-25 who drink at least twice a week and have experienced at least one recent heavy drinking event, provided they have an iPhone and no medical issues related to alcohol. As an unphased trial, this study offers a unique opportunity to contribute to understanding alcohol's impact on attention and behavior.

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 prior data suggests that alcohol is safe for cognitive studies?

Research shows that alcohol can affect the brain and behavior in various ways. Studies indicate that about 33% to 50% of people with alcohol use problems experience noticeable issues with thinking or movement. This suggests alcohol might impact how some people think and move.

Other studies have found that excessive alcohol consumption can worsen memory and thinking skills, especially in men. For younger individuals, such as teens and college students, alcohol can harm the brain, leading to problems with memory, learning, or decision-making.

While this evidence demonstrates that alcohol can cause various thinking problems, the study under consideration will explore alcohol’s effects on attention in a controlled setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard cognitive enhancers that often rely on medications like cholinesterase inhibitors or NMDA receptor antagonists, the treatment under study uses alcohol, which is not traditionally associated with cognitive improvement. Researchers are curious about alcohol because it has a unique mechanism that can potentially affect neurotransmitter systems differently than existing drugs. This exploration could uncover new pathways for cognitive enhancement, offering insights that differ greatly from conventional treatments.

What evidence suggests that alcohol affects attention in young adults?

Research shows that alcohol consumption can affect brain function. Some studies suggest a link between small to moderate alcohol intake and better brain performance. However, excessive drinking can double the risk of serious memory problems. For instance, men who consumed about 36 grams of alcohol daily experienced faster memory decline over ten years. While light to moderate drinking is sometimes associated with improved thinking skills, these effects can vary greatly depending on the amount consumed. Participants in this trial will receive alcohol to study its cognitive effects. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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)

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Alcohol Experimental Treatment 1 Intervention

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

Approved in United States as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in European Union as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Canada as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Japan as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in China as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Switzerland as Ethanol for:

• None (not approved as a therapeutic agent)

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of healthy young social drinkers, both below and above the legal intoxication limit (100 mg/dl), cognitive functions such as attention, concentration, and memory were significantly impaired, indicating that even low doses of ethanol can affect mental performance.

Motor speed was only impaired at higher ethanol levels, while fine coordination was affected at both low and high doses, with females experiencing greater impairments in memory functions compared to males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impairment of cognitive and psychomotor function by ethanol in social drinkers. Minocha, A., Barth, JT., Roberson, DG., et al.[2013]

Ethanol negatively impacts vigilance and continuous performance tasks, leading to both a decrease in overall performance and an increase in performance decline over time.

The overall performance drop is linked to ethanol's sedative effects, while the accelerated decline in performance is associated with a specific reduction in cognitive processing capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol intoxication in humans: effects on vigilance performance. Rohrbaugh, J., Stapleton, JM., Parasuraman, R., et al.[2013]

Ethanol has therapeutic benefits in various medical applications, including as an antidote for methanol and ethylene glycol poisoning, treatment for alcohol withdrawal syndrome, and as an antiseptic, with a generally positive risk-benefit ratio.

Recent advancements in medical technology have expanded ethanol's use as a precise embolization, sclerosing, or ablation agent, highlighting its effectiveness and safety in these new therapeutic roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Applications of Ethanol: A Review. Le Daré, B., Gicquel, T.[2020]

The study found that ethanol administration caused significant changes in neuromuscular and psychomotor functions in both rats and humans, indicating acute central nervous system effects.

Both species exhibited similar behavioral responses to ethanol, validating the use of rat models for studying neurobehavioral effects in humans, although the effects in humans were generally subtle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model studies for evaluating the acute neurobehavioral effects of complex hydrocarbon solvents I. Validation of methods with ethanol. McKee, RH., Lammers, JH., Hoogendijk, EM., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol and cognitive performance: a longitudinal study of older Japanese Americans. The Kame Project. Bond, GE., Burr, RL., McCurry, SM., et al.[2022]

In male Wistar rats, repeated moderate doses of ethanol led to temporary impairments in spatial learning and memory, which recovered after about 11-14 days, indicating that cognitive function can be affected by binge-like alcohol consumption.

The study also found that while spatial learning improved over time, reversal learning remained impaired for the entire two-week observation period, suggesting that cognitive flexibility is more persistently affected by ethanol exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated moderate-dose ethanol bouts impair cognitive function in Wistar rats. Kuzmin, A., Liljequist, S., Meis, J., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-related effects of ethanol on visual sustained attention and event-related potentials. Rohrbaugh, JW., Stapleton, JM., Parasuraman, R., et al.[2019]

Acute ethanol administration increased impulsivity in mice during a specific attention task (5-CSRTT) under conditions that promote premature responses, but did not affect overall attention or response accuracy.

The increase in impulsivity was linked to the action of ethanol on GABA(A) receptors, as similar effects were observed with the GABA(A) agonist diazepam, while the NMDA antagonist ketamine only affected one strain of mice, indicating different neurotransmitter system involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol effects on impulsivity in two mouse strains: similarities to diazepam and ketamine. Oliver, YP., Ripley, TL., Stephens, DN.[2021]

Ethanol can negatively impact cognition through various indirect effects such as intoxication and nutritional deficiencies, leading to conditions like Wernicke-Korsakoff disorder and lasting dementia at high doses.

Interestingly, at low-to-moderate doses, ethanol may have neuroprotective properties that could reduce the risk of dementia, including Alzheimer's, although its teratogenic effects during pregnancy raise concerns about any safe level of consumption for pregnant individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol and cognition: indirect effects, neurotoxicity and neuroprotection: a review. Brust, JC.[2021]

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