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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binge Drinkers | Experimental | Behavioral Intervention: Laboratory alcohol administration and cue exposure task; completion of EMA and blood sampling at all waves. |
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| Social Drinkers | Experimental | Behavioral Intervention: Identical procedures without the binge-level drinking phenotype; completion of EMA and blood sampling at all waves. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm | Behavioral | Mechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, 1-year follow-up, 2-year follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30-day EMA period after each assessment wave (baseline, 1 year, 2 years). |
| Composite biomarker index of neurobiological vulnerability |
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Inclusion Criteria:
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.
Inclusion Criteria
All Participants:
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
Exclusion Criteria:
All Participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Blaine, PhD | Contact | 6103041056 | skb0058@auburn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University MRI Center | Auburn | Alabama | 36832 | United States |
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.
Data will become available in 2033 and remain accessible thereafter.
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D007753 | Laboratories |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000072182 | Non-Medical Public and Private Facilities |
| D006268 | Health Facilities |
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Composite score derived from standardized z-scores across neural, neuroendocrine, and immune cue-reactivity measures representing multi-attribute vulnerability. |
| Baseline, 1-year follow-up, 2-year follow-up. |
| D005159 | Health Care Facilities Workforce and Services |