Alcohol and Immune Response

Not Applicable

Completed

• Conditions: Alcohol Drinking; Alcohol; Harmful Use
• Interventions: Drug: Alcohol, Ethyl; Other: Alcohol, Ethyl - placebo

• Registration Number: NCT03483389
• Lead Sponsor: Brown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Study Start: 2018-10-01
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alcohol, moderate dose	Alcohol, Ethyl	Alcohol, ethyl - Moderate dose
Alcohol, placebo	Alcohol, Ethyl	Alcohol, ethyl - Placebo
Alcohol, placebo	Alcohol, Ethyl - placebo	Alcohol, ethyl - Placebo
Alcohol, low dose	Alcohol, Ethyl	Alcohol, ethyl - Low dose
Alcohol, low dose	Alcohol, Ethyl - placebo	Alcohol, ethyl - Low dose
Alcohol, moderate dose	Alcohol, Ethyl - placebo	Alcohol, ethyl - Moderate dose

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States