Alcohol and Immune Response

Brown University

Status: Completed

Conditions: Alcohol; Harmful Use; Alcohol Drinking

Treatments: Other: Alcohol, Ethyl - placebo; Drug: Alcohol, Ethyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03483389

1710001919

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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76 participants in 3 patient groups

Alcohol, placebo

Experimental group

Description:

Alcohol, ethyl - Placebo

Treatment:

Drug: Alcohol, Ethyl

Other: Alcohol, Ethyl - placebo

Alcohol, low dose

Experimental group

Description:

Alcohol, ethyl - Low dose

Treatment:

Drug: Alcohol, Ethyl

Other: Alcohol, Ethyl - placebo

Alcohol, moderate dose

Experimental group

Description:

Alcohol, ethyl - Moderate dose

Treatment:

Drug: Alcohol, Ethyl

Other: Alcohol, Ethyl - placebo