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Alcohol and Immune Response

Sponsor
Brown University (Other)
Overall Status
Completed
CT.gov ID
NCT03483389
Collaborator
(none)
76
Enrollment
1
Location
3
Arms
32.6
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alcohol, Ethyl
  • Other: Alcohol, Ethyl - placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Jun 18, 2021
Actual Study Completion Date :
Jun 18, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma lipopolysaccharide (pg/ml) [0-4 hours]

      Plasma concentration of lipopolysaccharide, measured in picograms/ml

    2. Plasma lipopolysaccharide binding protein (ng/ml) [0-4 hours]

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

    3. Soluble cluster of differentiation 14 (ng/ml) [0-4 hours]

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

    4. Soluble cluster of differentiation 163 (ng/ml) [0-4 hours]

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

    Secondary Outcome Measures

    1. Response time in ms [0-4 hours]

      Response time in milliseconds, as measured by the NIH Toolbox and Cued Go/No-Go test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brown University Providence Rhode Island United States 02912

    Sponsors and Collaborators

    • Brown University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mollie Monnig, Assistant Professor of Behavioral and Social Sciences, Brown University
    ClinicalTrials.gov Identifier:
    NCT03483389
    Other Study ID Numbers:
    • 1710001919
    First Posted:
    Mar 30, 2018
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alcohol Drinking
    Ethanol

    Study Results

    No Results Posted as of Jul 27, 2021