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Alcohol and Immune Response

Primary Purpose

Alcohol Drinking, Alcohol; Harmful Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol, Ethyl
Alcohol, Ethyl - placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Drinking

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alcohol, placebo

Alcohol, low dose

Alcohol, moderate dose

Arm Description

Alcohol, ethyl - Placebo

Alcohol, ethyl - Low dose

Alcohol, ethyl - Moderate dose

Outcomes

Primary Outcome Measures

Plasma lipopolysaccharide (pg/ml)
Plasma concentration of lipopolysaccharide, measured in picograms/ml
Plasma lipopolysaccharide binding protein (ng/ml)
Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml
Soluble cluster of differentiation 14 (ng/ml)
Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml
Soluble cluster of differentiation 163 (ng/ml)
Plasma concentration of soluble cluster of differentiation 163, measured in nanograms/ml

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2018
Last Updated
July 26, 2021
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT03483389
Brief Title
Alcohol and Immune Response
Official Title
Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol; Harmful Use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol, placebo
Arm Type
Experimental
Arm Description
Alcohol, ethyl - Placebo
Arm Title
Alcohol, low dose
Arm Type
Experimental
Arm Description
Alcohol, ethyl - Low dose
Arm Title
Alcohol, moderate dose
Arm Type
Experimental
Arm Description
Alcohol, ethyl - Moderate dose
Intervention Type
Drug
Intervention Name(s)
Alcohol, Ethyl
Other Intervention Name(s)
Alcohol
Intervention Description
Randomized within-subjects design
Intervention Type
Other
Intervention Name(s)
Alcohol, Ethyl - placebo
Other Intervention Name(s)
Placebo
Intervention Description
Randomized within-subjects design
Primary Outcome Measure Information:
Title
Plasma lipopolysaccharide (pg/ml)
Description
Plasma concentration of lipopolysaccharide, measured in picograms/ml
Time Frame
0-4 hours
Title
Plasma lipopolysaccharide binding protein (ng/ml)
Description
Plasma concentration of lipopolysaccharide binding protein, measured in nanograms/ml
Time Frame
0-4 hours
Title
Soluble cluster of differentiation 14 (ng/ml)
Description
Plasma concentration of soluble cluster of differentiation 14, measured in nanograms/ml
Time Frame
0-4 hours
Title
Soluble cluster of differentiation 163 (ng/ml)
Description
Plasma concentration of soluble cluster of differentiation 163, measured in nanograms/ml
Time Frame
0-4 hours
Secondary Outcome Measure Information:
Title
Response time in ms
Description
Response time in milliseconds, as measured by the NIH Toolbox and Cued Go/No-Go test
Time Frame
0-4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Alcohol and Immune Response

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