fMRI Study of Decision-Making for Alcohol Consumption

Overseen By Michael Amlung, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Anti-seizure medications

Disqualifiers: Psychotic disorder, Bipolar, PTSD, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the brain reacts when making decisions about drinking alcohol, particularly when important activities are planned for the next day. Researchers use brain scans (fMRI) to observe communication between different brain areas and assess whether alcohol problems influence these decisions. Participants will encounter scenarios where they feel responsible for tasks (the "Responsibility condition") versus when they do not. This trial suits individuals who drink heavily, have significant responsibilities like a job or caregiving, and are not currently in alcohol treatment. As an unphased study, it offers a unique opportunity to contribute to understanding decision-making in real-life scenarios.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anti-seizure medication, you may be excluded from participating.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anti-seizure medication or have a serious medical illness, you may not be eligible to participate.

What prior data suggests that this fMRI study is safe for participants?

Research has shown that the "responsibility condition" in this study examines how thinking about next-day responsibilities can influence alcohol consumption choices. Early results suggest that considering important upcoming tasks may lead to reduced drinking. This study focuses on decision-making rather than testing a new drug or medical treatment.

As this trial does not involve a new drug or medical device, typical safety concerns like side effects do not apply. Instead, it explores how individuals consider their responsibilities. Therefore, the "responsibility condition" is safe, as it involves making thoughtful choices rather than taking a new medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how taking responsibility affects decision-making related to alcohol consumption, a factor not typically addressed by standard treatments like counseling or medication. Unlike traditional approaches that focus on reducing alcohol intake directly, this study investigates the psychological and neurological processes involved when individuals are made to feel responsible for their drinking choices. By using an fMRI to observe brain activity, researchers hope to gain new insights into how responsibility can impact drinking behavior, potentially leading to novel intervention strategies that enhance personal accountability and reduce alcohol misuse.

What evidence suggests that this trial's treatments could be effective for decision-making about alcohol consumption?

Research shows that brain activity affects how people decide about drinking alcohol. One study found that people dependent on alcohol often choose risky options, such as pursuing big but uncertain rewards. Other research has shown that certain brain areas become more active when individuals with alcohol use disorders (AUD) make decisions about alcohol. Additionally, the brain's reaction to images of alcohol can predict future heavy drinking. These findings suggest that brain activity can influence drinking decisions, which the responsibility condition in this trial aims to explore. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Amlung, PhD

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

This trial is for adults aged 21-55 who drink heavily, defined as at least 14 drinks per week for men or 7 for women, and have had weekly heavy drinking episodes. Participants must have significant responsibilities like work, school, or caregiving, speak English, and be able to consent. Excluded are those with major psychiatric illnesses, brain injuries, current alcohol treatment seekers, positive breath alcohol tests on session days, MRI contraindications (like metal implants), seizure histories or substance use disorders.

Inclusion Criteria

Belong to a category with significant responsibilities, such as being currently employed, a current student, or a caregiver with significant responsibilities

I am between 21 and 55 years old.

Able to give informed consent

Exclusion Criteria

Diagnostic and Statistical Manual Version-5 substance use disorder (except nicotine)

Currently engaged in treatment or seeking treatment for alcohol-related problems

I have a history of seizures or am on anti-seizure medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Interview

Participants undergo a baseline interview conducted virtually or in-person

1 session

1 visit (virtual or in-person)

MRI Scanning Session

Participants complete hypothetical alcohol purchase tasks during an MRI scan to examine brain activity

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the MRI scanning session

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Responsibility condition

Trial Overview

The study uses fMRI scans to look at how the brain decides about drinking when faced with everyday situations that might include important tasks the next day. It also explores if having more severe alcohol-related problems affects these brain activities and choices and examines connected networks in different brain areas.

How Is the Trial Designed?

Group I: Responsibility vs No Responsibility Experimental Treatment 1 Intervention

Within-subjects experimental manipulation of responsibility vs. no-responsibility condition

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

Published Research Related to This Trial

The study involved 24 heavy drinkers using fMRI to explore how their brains respond to decisions about alcohol consumption based on varying prices, revealing that different brain regions are activated depending on whether the decision is influenced by cost.

Findings showed that when participants considered the cost of alcohol, there was increased activity in frontostriatal regions, indicating a link between cognitive deliberation and reward value, while also highlighting the role of the anterior insula in decision-making related to alcohol demand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neuroeconomics of alcohol demand: an initial investigation of the neural correlates of alcohol cost-benefit decision making in heavy drinking men. MacKillop, J., Amlung, MT., Acker, J., et al.[2021]

Alcohol-dependent patients (n = 43) show impaired decision-making abilities compared to healthy volunteers (n = 35), particularly in their ability to consider alternative choices after experiencing negative outcomes.

This impairment is linked to reduced activity in the medial prefrontal cortex, suggesting that difficulties in integrating alternative options may explain why individuals with addiction continue substance use despite knowing the harmful consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and Neural Signatures of Reduced Updating of Alternative Options in Alcohol-Dependent Patients during Flexible Decision-Making. Reiter, AM., Deserno, L., Kallert, T., et al.[2020]

Alcohol-dependent individuals show reduced motivation for tasks requiring high effort compared to healthy controls, indicating a difference in how they value effort-related rewards.

fMRI results revealed that alcohol-dependent participants had increased activity in brain areas associated with reward processing during low-effort tasks, suggesting a heightened sensitivity to rewards that may contribute to their addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered Striatal Response During Effort-Based Valuation and Motivation in Alcohol-Dependent Individuals. Grodin, EN., Steckler, LE., Momenan, R.[2018]

Individuals with a family history of alcoholism (FHP) show increased brain activation in areas related to impulse control during tasks, particularly FHP males, suggesting a neural basis for their heightened risk of addiction.

Higher levels of self-reported impulsivity in FHP individuals correlate with greater brain activity in impulse control regions, indicating that impulsivity may play a significant role in the risk for alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural correlates of impulsivity in healthy males and females with family histories of alcoholism. DeVito, EE., Meda, SA., Jiantonio, R., et al.[2022]

In a study involving 22 early-abstinent alcoholic patients and 18 controls, researchers found that decision-making performance, measured by the Cambridge Gambling Task, was linked to grey-matter density and white-matter integrity in the brain.

Alcoholic patients exhibited slower decision-making times, which were associated with reduced grey-matter density in the supplementary motor area, suggesting that brain changes in AUD may impair cognitive processing speed and decision-making abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased information processing speed and decision-making performance in alcohol use disorder: combined neurostructural evidence from VBM and TBSS. Galandra, C., Crespi, C., Basso, G., et al.[2021]

The study involved 12 healthy participants and used fMRI to identify brain areas activated during risk-taking decisions, revealing that safe choices activated the inferior frontal cortex and risky choices activated the medial frontal cortex and nucleus accumbens.

The activation of the nucleus accumbens was positively correlated with harm avoidance traits, suggesting that understanding these brain circuits could help in studying and addressing problematic risk-taking behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective activation of the nucleus accumbens during risk-taking decision making. Matthews, SC., Simmons, AN., Lane, SD., et al.[2019]

Heavy drinking men with alcohol use disorders (AUDs) showed a tendency for more impulsive decision-making in delayed reward discounting (DRD) tasks compared to those without AUDs, indicating a behavioral pattern linked to their condition.

Neuroimaging revealed that AUD+ individuals had increased activation in brain regions related to cognitive control and decision-making, such as the dorsolateral prefrontal cortex and posterior parietal cortex, suggesting altered neural mechanisms in processing delayed rewards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissociable brain signatures of choice conflict and immediate reward preferences in alcohol use disorders. Amlung, M., Sweet, LH., Acker, J., et al.[2021]

Alcohol-dependent individuals show reduced brain activation in the right dorsolateral prefrontal cortex (rDLPFC) when making risky decisions compared to control participants, indicating a potential impairment in their ability to evaluate risk.

Additionally, alcohol-dependent participants exhibited less activation in the insula during loss events, which may contribute to their decision-making deficits related to addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diminished cortical response to risk and loss during risky decision making in alcohol use disorder. Burnette, EM., Grodin, EN., Ghahremani, DG., et al.[2022]

Increased decision latency in individuals with alcohol use disorder (AUD) is linked to altered brain activity rather than just psychomotor slowing, as shown in a study involving 22 AUD patients and 19 matched controls using the Cambridge Gambling Task.

The study found that AUD patients exhibited heightened activity in the cingulate node of the anterior salience network, which may serve as a compensatory mechanism for decreased coherence in brain activity, suggesting complex neural changes that could inform future treatments for decision-making impairments in AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased decision latency in alcohol use disorder reflects altered resting-state synchrony in the anterior salience network. Canessa, N., Basso, G., Carne, I., et al.[2021]

In a study using fMRI with participants receiving either alcohol or a placebo, it was found that alcohol significantly increased risk-taking behavior, especially in those who felt more stimulated by the alcohol.

The brain imaging revealed that alcohol heightened activation in the striatum during risky decision-making and reduced responses to both winning and losing feedback in areas like the caudate and insula, suggesting a dual mechanism of enhancing reward sensitivity while dampening feedback responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of intravenous alcohol on the neural correlates of risky decision making in healthy social drinkers. Gilman, JM., Smith, AR., Ramchandani, VA., et al.[2021]

Neuroeconomics research indicates that alcohol use disorders (AUDs) are linked to impaired decision-making due to abnormal neural functioning, particularly in the balance between impulsive and inhibitory signals in the brain.

Magnetic resonance imaging (MRI) studies suggest that excessive alcohol exposure weakens activity in the ventromedial prefrontal cortex and alters connectivity between brain regions, which may lead to habitual actions and compulsive drinking despite negative consequences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The alcoholic brain: neural bases of impaired reward-based decision-making in alcohol use disorders. Galandra, C., Basso, G., Cappa, S., et al.[2018]

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