Alcohol and Immune Response

Alcohol Drinking Clinical Trial

Official title:

Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483389
• Other study ID #: 1710001919
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol; Harmful Use

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