Alcohol Cue Reactivity for Alcohol Consumption

(MIND Trial)

Overseen By Sara Blaine, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Disqualifiers: Psychotic disorder, Substance use disorder, PTSD, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the brain and body react to images of alcohol compared to water. Researchers seek to learn how these reactions relate to drinking habits, potentially aiding in the development of new treatments for Alcohol Use Disorders. Participants will undergo MRI scans, blood tests, and an Alcohol Taste Test as part of the Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm. The trial seeks regular beer drinkers aged 21-25, including those who binge drink and those who drink socially without bingeing. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative treatments for Alcohol Use Disorders.

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, you must pass a toxicology screening for substances at all study appointments, which might affect certain medications.

What prior data suggests that this protocol is safe for participants?

Studies have shown that participating in the Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm is generally safe. Research indicates that these lab settings often study reactions to alcohol-related cues, like pictures of alcohol. These studies help researchers understand behaviors related to alcohol use.

Participants in these studies view alcohol-related images and sometimes consume small, controlled amounts of alcohol. The goal is to measure bodily and brain responses. This method is well-tolerated, with most participants not experiencing serious side effects. However, some may feel mild discomfort, such as anxiety or cravings, but these effects are temporary and manageable.

The research focuses on understanding reactions to alcohol cues, not on developing a new treatment. Therefore, the risks are low and mainly involve normal responses to seeing or thinking about alcohol. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm because it offers a new way to understand and potentially reduce alcohol consumption. Unlike standard treatments that often focus on medication or therapy alone, this approach uses behavioral interventions to directly expose participants to alcohol cues in a controlled setting. By studying how people react to these cues, scientists hope to uncover the psychological and physiological triggers of binge and social drinking. This could lead to more personalized and effective strategies for managing alcohol use, offering a fresh perspective beyond the typical focus on abstinence or medication.

What evidence suggests that this trial's treatments could be effective for understanding alcohol use behaviors?

This trial will compare how the brains of binge drinkers and social drinkers react to alcohol-related images. Research has shown that the brain's response to such images can predict drinking habits. Studies have found that alcohol-related images trigger more activity in brain areas associated with reward and craving than neutral images. This method helps researchers understand how the brain processes alcohol and may explain why some people drink more. Other research suggests this approach can help test new treatments for Alcohol Use Disorders by serving as an early indicator of their effectiveness. Understanding these brain responses might lead to better ways to manage or treat drinking problems. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who regularly drink alcohol. They should be willing to undergo MRI scans, blood draws, and participate in an Alcohol Taste Test involving beer consumption. Participants are required to complete psychological questionnaires and multiple surveys on a smartphone over the course of three years.

Inclusion Criteria

Able to read and write in English and complete study evaluations

Able to provide negative breathalyzer and negative toxicology screenings for substances at all study appointments

Able to provide written and verbal consent

Exclusion Criteria

I am not pregnant or breastfeeding.

Meets criteria for current or past moderate or severe substance use disorder

Any contraindications for MRI (e.g., medical devices in the body, claustrophobia, etc)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete psychological questionnaires and undergo MRI scans with blood draws. Alcohol Taste Test is conducted after each MRI scan.

3 visits over 2 weeks

3 visits (in-person)

1-Year Follow-up

Participants undergo MRI scans with blood draws and Alcohol Taste Test. EMA surveys conducted for 21 days.

2 visits over 2 weeks

2 visits (in-person)

2-Year Follow-up

Participants undergo MRI scans with blood draws and Alcohol Taste Test. EMA surveys conducted for 21 days.

2 visits over 2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm

Trial Overview Researchers are studying how brain blood flow, cortisol levels, and interleukin-6 immune factors respond to images of alcohol compared to water. The study aims to understand the relationship between brain processing of environmental cues and drinking behavior.

How Is the Trial Designed?

Group I: Social Drinkers Experimental Treatment 1 Intervention

Behavioral Intervention: Identical procedures without the binge-level drinking phenotype; completion of EMA and blood sampling at all waves.

Group II: Binge Drinkers Experimental Treatment 1 Intervention

Behavioral Intervention: Laboratory alcohol administration and cue exposure task; completion of EMA and blood sampling at all waves.

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4167612/

Human Laboratory Paradigms in Alcohol Research - PMC This review of the literature focuses on human laboratory studies of subjective intoxication, alcohol craving, anxiety, and behavioral economics.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acer.70170?af=R

The alcohol cue‐exposure paradigm as a screening tool ... These data underscore the paradigm's potential as an early efficacy marker for AUD medication development, particularly for pharmacotherapies ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2783802/

Alcohol Cue Reactivity Task Development - PMC This project systematically created an alcohol cue reactivity task for studies with non-drinkers, using well-characterized stimuli.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763421002736

Neurobiological correlates of cue-reactivity in alcohol-use ... Our meta-analysis revealed that alcohol cues evoke greater cue-reactivity than neutral cues in the mesocorticolimbic circuit and lower reactivity in the ...

5. addictions.psych.ucla.edu addictions.psych.ucla.edu/wp-content/uploads/sites/160/2018/01/Experimental-psychopathology-paradigms-for-alcohol-use-disorder-Applications-for-translational-research.pdf

Experimental-psychopathology-paradigms-for-alcohol-use- ... Specifically we review alcohol administration, self-administration, cue-reactivity, and stress-reactivity paradigms. We also provide an introduction to the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12368849/

Who is alcohol cue-reactive? A machine learning approach Alcohol cue-exposure paradigms are widely used in experimental laboratory research to study the role of alcohol cue-reactivity in the clinical ...