Alcohol and Immune Response

Study Overview
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Brief Summary
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This study investigates how alcohol affects the immune system and behavior in healthy adults. The study also will examine how an individual's typical drinking habits may affect the immune system's response to alcohol.

Official Title
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Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking

Conditions
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Alcohol Drinking, Alcohol; Harmful Use

Intervention / Treatment
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* Drug: Alcohol, Ethyl
* Other: Alcohol, Ethyl - placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 21-55 years Able to speak and read English Regular use of alcohol Weight > or = to 110 lbs and body mass index (BMI) in the 18.5-30 kg/m2 range No self-reported use of drugs Exclusion Criteria: Currently seeking treatment for alcohol or drug use Chronic disease Use of certain medications GI disorders Daily/near-daily use of NSAIDs Positive urine test for certain drugs History of withdrawal symptoms precipitated by alcohol abstinence Clinical Institute Withdrawal Assessment for Alcohol score greater than or equal to 10 History of seizures Current major psychiatric disorder History of adverse reaction to standard blood draw Inability to abstain from tobacco for 8 hours Inability to abstain from cannabis for 48 hours Pregnant, breastfeeding, or may become pregnant

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol, placebo<br>Alcohol, ethyl - Placebo | Drug: Alcohol, Ethyl<br>* Randomized within-subjects design<br>* Other names: Alcohol;Other: Alcohol, Ethyl - placebo<br>* Randomized within-subjects design<br>* Other names: Placebo;|
| Experimental: Alcohol, low dose<br>Alcohol, ethyl - Low dose | Drug: Alcohol, Ethyl<br>* Randomized within-subjects design<br>* Other names: Alcohol;Other: Alcohol, Ethyl - placebo<br>* Randomized within-subjects design<br>* Other names: Placebo;|
| Experimental: Alcohol, moderate dose<br>Alcohol, ethyl - Moderate dose | Drug: Alcohol, Ethyl<br>* Randomized within-subjects design<br>* Other names: Alcohol;Other: Alcohol, Ethyl - placebo<br>* Randomized within-subjects design<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipopolysaccharide (pg/ml) | Plasma concentration of lipopolysaccharide, measured in picograms/ml | 0-4 hours | 
| Plasma lipopolysaccharide binding protein (ng/ml) | Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml | 0-4 hours | 
| Soluble cluster of differentiation 14 (ng/ml) | Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml | 0-4 hours | 
| Soluble cluster of differentiation 163 (ng/ml) | Plasma concentration of soluble cluster of differentiation 163, measured in nanograms/ml | 0-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response time in ms | Response time in milliseconds, as measured by the NIH Toolbox and Cued Go/No-Go test | 0-4 hours |