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Completed

NCT Number: NCT03483389

Alcohol and Immune Response

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.

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Key information

Conditions

Alcohol Drinking Alcohol; Harmful Use Behavior Drinking Behavior

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol, Ethyl

Drug

Randomized within-subjects design

Other names: Alcohol

Alcohol, Ethyl - placebo

Other

Randomized within-subjects design

Other names: Placebo

Primary outcomes

  1. Plasma lipopolysaccharide (pg/ml)

    Time frame: 0-4 hours

    Plasma concentration of lipopolysaccharide, measured in picograms/ml

  2. Plasma lipopolysaccharide binding protein (ng/ml)

    Time frame: 0-4 hours

    Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml

  3. Soluble cluster of differentiation 14 (ng/ml)

    Time frame: 0-4 hours

    Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml

  4. Soluble cluster of differentiation 163 (ng/ml)

    Time frame: 0-4 hours

    Plasma concentration of soluble cluster of differentiation 163, measured in nanograms/ml

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2018
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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