Multimodal Immune and Neuroendocrine Assessment in Drinkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm.
- Who it may be relevant to
- Registry conditions: Alcohol Drinking. Basic parameters: 21 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multimodal Assessment of Neural, Neuroendocrine, and Immune Cue Responses in Binge Drinkers in the Laboratory and Real World
Overview
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.
Interventions
- Behavioral Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm
Mechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior.
Primary outcome measures
- Neural cue reactivity to alcohol stimuli (fMRI BOLD response) [Time frame: Baseline, 1-year follow-up, 2-year follow-up.]
- Cortisol and IL-6 reactivity to alcohol cues [Time frame: Baseline, 1-year follow-up, 2-year follow-up.]
- Alcohol craving and consumption following cue exposure [Time frame: Baseline, 1-year follow-up, 2-year follow-up.]
Secondary outcome measures (2)
- 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.]
Eligibility criteria
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:
- 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.
- 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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Auburn University MRI Center — Auburn
Identifiers
NCT: NCT07220148 · STUDY00000843