Alcohol and Immune Response

Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03483389

Enrollment

Registered

2018-03-30

Start date

2018-10-01

Completion date

2021-06-18

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Alcohol; Harmful Use

Brief summary

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.

Interventions

DRUGAlcohol, Ethyl

Randomized within-subjects design

OTHERAlcohol, Ethyl - placebo

Randomized within-subjects design

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026