Alcohol and Immune Response

July 26, 2021 updated by: Mollie Monnig, Brown University

Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol, placebo
Alcohol, ethyl - Placebo
Drug: Alcohol, Ethyl
Randomized within-subjects design
Other Names:
  • Alcohol
Other: Alcohol, Ethyl - placebo
Randomized within-subjects design
Other Names:
  • Placebo
Experimental: Alcohol, low dose
Alcohol, ethyl - Low dose
Drug: Alcohol, Ethyl
Randomized within-subjects design
Other Names:
  • Alcohol
Other: Alcohol, Ethyl - placebo
Randomized within-subjects design
Other Names:
  • Placebo
Experimental: Alcohol, moderate dose
Alcohol, ethyl - Moderate dose
Drug: Alcohol, Ethyl
Randomized within-subjects design
Other Names:
  • Alcohol
Other: Alcohol, Ethyl - placebo
Randomized within-subjects design
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma lipopolysaccharide (pg/ml)
Time Frame: 0-4 hours
Plasma concentration of lipopolysaccharide, measured in picograms/ml
0-4 hours
Plasma lipopolysaccharide binding protein (ng/ml)
Time Frame: 0-4 hours
Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml
0-4 hours
Soluble cluster of differentiation 14 (ng/ml)
Time Frame: 0-4 hours
Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml
0-4 hours
Soluble cluster of differentiation 163 (ng/ml)
Time Frame: 0-4 hours
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
Time Frame: 0-4 hours
Response time in milliseconds, as measured by the NIH Toolbox and Cued Go/No-Go test
0-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

June 18, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1710001919

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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