Multimodal Immune and Neuroendocrine Assessment in Drinkers
ConditionAlcohol Drinking
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-25
SponsorAuburn University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm
BehavioralMechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior.
Treatment groups
234 Participants
are divided into 2 treatment groupsGroup A: Binge DrinkersExperimental treatment 1 intervention
Group B: Social DrinkersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 1-year follow-up, 2-year follow-up.2
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.
Time frame
Baseline, 1-year follow-up, 2-year follow-up.3
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.
Time frame
Baseline, 1-year follow-up, 2-year follow-up.Secondary outcomes
1
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.
Time frame
30-day EMA period after each assessment wave (baseline, 1 year, 2 years).2
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.
Time frame
Baseline, 1-year follow-up, 2-year follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: