Alcohol DrinkingMINDNCT07220148
Multimodal Immune and Neuroendocrine Assessment in Drinkers
A study testing Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm in people with Alcohol Drinking, run by Auburn University at 1 site in United States.
Trial summary
The goal of this clinical trial is to better understand how blood flow in the brain, levels of the hormone, cortisol, and levels of an immune factor, interleukin-6, change in response to pictures of alcohol versus water pictures of water in healthy people who regularly consume alcohol. Read more about this study
- Who is it for?
- Ages 21 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In this study, researchers will recruit 234 individuals who report binge use of alcohol or who consume alcohol moderately with no episodes of binge drinking. All participants will be recruited from the community primarily through advertisements in local newspapers, online venues like craigslist, flyers, and list-serve emails, as well as through radio and other media advertisements.
- All Participants:
- Male and Females between the ages of 21-25
- 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.
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- Must be a beer drinker (not exclusively), to ensure subjects are not averse to the taste of beverages presented in the ATT
- BMI of 18-35
- Binge Drinkers:
- At least twice per month binge drinking and weekly alcohol use of at least 8 standard drinks/week females or 15 or more drinks for males for the past year, with binge drinking defined as drinking enough alcohol that brings blood alcohol concentration to 0.08 percent or higher in about 2 hours, which is typically equivalent to consuming 5 or more drinks for males, or 4 or more drinks for females.
- Social Drinkers:
- at least weekly alcohol use for the past 6 months not to exceed 7 standard drinks/wk for women and 14 standard drinks/week for males, with no episodes of binge drinking in the past year
Who cannot join
- All Participants:
- Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
- meets criteria for current or past moderate or severe substance use disorder
- women who are pregnant or lactating
- inability to give informed consent
- any contraindications for MRI (e.g., medical devices in the body, claustrophobia, etc)
- current PTSD or acute stress disorder
- other illicit drug use as determined by a urine drug screen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Auburn University MRI Center
Auburn, Alabama, 36832
Tom Denney, PhD, dennets@auburn.edu
About this study
Official title: Multimodal Assessment of Neural, Neuroendocrine, and Immune Cue Responses in Binge Drinkers in the Laboratory and Real World
The goal of this clinical trial is to better understand how blood flow in the brain, levels of the hormone, cortisol, and levels of an immune factor, interleukin-6, change in response to pictures of alcohol versus water pictures of water in healthy people who regularly consume alcohol. Researchers will learn about how the brain processes our environment and how it relates to people's drinking behaviors. This information is important because it may allow us to develop new treatments for Alcohol Use Disorders.
Participants will be asked to fill out psychological questionnaires at the first appointment. Then, they will do MRI scans with blood draws at visits 2-6. After each MRI scan, participants will undergo the Alcohol Taste Test, which involves drinking beer.
There will be a total of 3 visits at baseline, 2 visits one year later, and 2 visits one year after that. Each visit will last 2 hours. Each year, participants will do 21 days of surveys on a smart phone (4 surveys a day; each survey takes less than 2 minutes). The total time commitment for the entire study will be 23 hours.
- Conditions
- Alcohol Drinking
- Being tested
- Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Cue Reactivity and Laboratory Alcohol Administration ParadigmBehavioural
Mechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior.
| Study group | Role | What they receive |
|---|---|---|
| Binge Drinkers | Experimental | Behavioral Intervention: Laboratory alcohol administration and cue exposure task; completion of EMA and blood sampling at all waves. Receives: Behavioral: Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm |
| Social Drinkers | Experimental | Behavioral Intervention: Identical procedures without the binge-level drinking phenotype; completion of EMA and blood sampling at all waves. Receives: Behavioral: Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural cue reactivity to alcohol stimuli (fMRI BOLD response)
Change in blood-oxygen-level dependent (BOLD) activation to alcohol versus neutral cues in regions of interest (e.g., medial prefrontal cortex, posterior cingulate cortex, striatum) measured using 7 Tesla functional MRI.
Measured: Baseline, 1-year follow-up, 2-year follow-up.
Cortisol and IL-6 reactivity to alcohol cues
Change in plasma cortisol and interleukin-6 concentrations (pg/mL) from pre- to post-cue exposure in the laboratory alcohol administration session.
Measured: Baseline, 1-year follow-up, 2-year follow-up.
Alcohol craving and consumption following cue exposure
Alcohol craving ratings on the Alcohol Urge Questionnaire (1-7 visual analog scale, high scores mean worse outocme) and total volume of alcohol consumed (mL) during the Alcohol Taste Test following cue exposure.
Measured: Baseline, 1-year follow-up, 2-year follow-up.
Secondary outcomes (2)
Real-world craving and drinking behavior (EMA)
Ecological Momentary Assessment (EMA) measures of craving, alcohol use, and contextual factors collected via smartphone app 3-5 times daily for 30 days following each lab session.
Measured: 30-day EMA period after each assessment wave (baseline, 1 year, 2 years).
Composite biomarker index of neurobiological vulnerability
Composite score derived from standardized z-scores across neural, neuroendocrine, and immune cue-reactivity measures representing multi-attribute vulnerability.
Measured: Baseline, 1-year follow-up, 2-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study startApr 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara K Blaine, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220148
- Sponsor's protocol ID
- STUDY00000843
- Acronym
- MIND
- Status last verified
- Oct 2025
- First submitted
- 19 Oct 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project will generate de-identified multimodal data from 234 participants (sex-balanced binge and non-binge alcohol users), including demographics, questionnaires, EMA (stress, craving, drinking), fMRI alcohol cue-reactivity data, cortisol and IL-6 assays, and Alcohol Taste Test results. De-identified participant-level data, survey instruments, codebooks, and metadata (DDI-compliant PDFs) will be shared via the NIDA-funded ICPSR-NAHDAP repository. MRI data will be defaced and formatted in BIDS; other data will be in .csv format, processed using R, FSL, Freesurfer, Matlab, SAS, SPSS, and Mplus, following ICPSR documentation standards. Data will be deposited within two years of project completion (or publication) and maintained in perpetuity. Access will be restricted to qualified researchers under a data-use agreement and IRB approval, with all identifiers stored separately. The PI will oversee compliance and privacy protections under NIH Certificate of Confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Neural, Neuroendocrine, and Immune Cue Responses in Binge Drinkers in the Laboratory and Real World
- ClinicalTrials.gov ID
- NCT07220148
- Acronym / sponsor ID
- MIND / STUDY00000843
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 23 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to better understand how blood flow in the brain, levels of the hormone, cortisol, and levels of an immune factor, interleukin-6, change in response to pictures of alcohol versus water pictures of water in healthy people who regularly consume alcohol. Researchers will learn about how the brain processes our environment and how it relates to people's drinking behaviors. This information is important because it may allow us to develop new treatments for Alcohol Use Disorders.
Participants will be asked to fill out psychological questionnaires at the first appointment. Then, they will do MRI scans with blood draws at visits 2-6. After each MRI scan, participants will undergo the Alcohol Taste Test, which involves drinking beer.
There will be a total of 3 visits at baseline, 2 visits one year later, and 2 visits one year after that. Each visit will last 2 hours. Each year, participants will do 21 days of surveys on a smart phone (4 surveys a day; each survey takes less than 2 minutes). The total time commitment for the entire study will be 23 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binge Drinkers | Experimental | Behavioral: Alcohol Cue Reactivity and Laboratory Alcohol Administration ParadigmBehavioral Intervention: Laboratory alcohol administration and cue exposure task; completion of EMA and blood sampling at all waves. |
| Social Drinkers | Experimental | Behavioral: Alcohol Cue Reactivity and Laboratory Alcohol Administration ParadigmBehavioral Intervention: Identical procedures without the binge-level drinking phenotype; completion of EMA and blood sampling at all waves. |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- In this study, researchers will recruit 234 individuals who report binge use of alcohol or who consume alcohol moderately with no episodes of binge drinking. All participants will be recruited from the community primarily through advertisements in local newspapers, online venues like craigslist, flyers, and list-serve emails, as well as through radio and other media advertisements.
- Male and Females between the ages of 21-25
- 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.
Key exclusion criteria (8 listed)
- Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
- meets criteria for current or past moderate or severe substance use disorder
- women who are pregnant or lactating
- inability to give informed consent
- any contraindications for MRI (e.g., medical devices in the body, claustrophobia, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Cue Reactivity and Laboratory Alcohol Administration ParadigmMechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior. | Behavioural | Binge Drinkers, Social Drinkers |
Primary outcome
Neural cue reactivity to alcohol stimuli (fMRI BOLD response)
Time frame: Baseline, 1-year follow-up, 2-year follow-up.
Change in blood-oxygen-level dependent (BOLD) activation to alcohol versus neutral cues in regions of interest (e.g., medial prefrontal cortex, posterior cingulate cortex, striatum) measured using 7 Tesla functional MRI.
Cortisol and IL-6 reactivity to alcohol cues
Time frame: Baseline, 1-year follow-up, 2-year follow-up.
Change in plasma cortisol and interleukin-6 concentrations (pg/mL) from pre- to post-cue exposure in the laboratory alcohol administration session.
Alcohol craving and consumption following cue exposure
Time frame: Baseline, 1-year follow-up, 2-year follow-up.
Alcohol craving ratings on the Alcohol Urge Questionnaire (1-7 visual analog scale, high scores mean worse outocme) and total volume of alcohol consumed (mL) during the Alcohol Taste Test following cue exposure.
2 secondary outcomes
Real-world craving and drinking behavior (EMA)
Time frame: 30-day EMA period after each assessment wave (baseline, 1 year, 2 years).
Composite biomarker index of neurobiological vulnerability
Time frame: Baseline, 1-year follow-up, 2-year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: Yes. This project will generate de-identified multimodal data from 234 participants (sex-balanced binge and non-binge alcohol users), including demographics, questionnaires, EMA (stress, craving, drinking), fMRI alcohol cue-reactivity data, cortisol and IL-6 assays, and Alcohol Taste Test results. De-identified participant-level data, survey instruments, codebooks, and metadata (DDI-compliant PDFs) will be shared via the NIDA-funded ICPSR-NAHDAP repository. MRI data will be defaced and formatted in BIDS; other data will be in .csv format, processed using R, FSL, Freesurfer, Matlab, SAS, SPSS, and Mplus, following ICPSR documentation standards. Data will be deposited within two years of project completion (or publication) and maintained in perpetuity. Access will be restricted to qualified researchers under a data-use agreement and IRB approval, with all identifiers stored separately. The PI will oversee compliance and privacy protections under NIH Certificate of Confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm in people with Alcohol Drinking, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Blaine, PhD (6103041056, skb0058@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural cue reactivity to alcohol stimuli (fMRI BOLD response) (time frame: Baseline, 1-year follow-up, 2-year follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.