Alcohol Drinking Clinical Trial
Official title:
Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking
Verified date | July 2021 |
Source | Brown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brown University | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Brown University |
United States,
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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