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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03483389
Other study ID # 1710001919
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date June 18, 2021

Study information

Verified date July 2021
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date June 18, 2021
Est. primary completion date June 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Alcohol, Ethyl
Randomized within-subjects design
Other:
Alcohol, Ethyl - placebo
Randomized within-subjects design

Locations

Country Name City State
United States Brown University Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

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