ClinicalTrials.gg
CompletedNCT03483389Updated Jul 27, 2021

Alcohol and Immune Response

An interventional study of Alcohol, Ethyl and Alcohol, Ethyl - placebo in Alcohol Drinking and Alcohol; Harmful Use, sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-27.

Sponsored by Brown University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Drinking
  • Alcohol; Harmful Use

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03

In context

Alcohol Drinking

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's enrollment of 76 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ages 21-55 years
  • Able to speak and read English
  • Regular use of alcohol
  • Weight > or = to 110 lbs and (BMI) in the 18.5-30 kg/m2 range
  • No self-reported use of drugs

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Alcohol, placebo

    Alcohol, ethyl - Placebo

    Drug: Alcohol, Ethyl · Other: Alcohol, Ethyl - placebo

  • Experimental
    Alcohol, low dose

    Alcohol, ethyl - Low dose

    Drug: Alcohol, Ethyl · Other: Alcohol, Ethyl - placebo

  • Experimental
    Alcohol, moderate dose

    Alcohol, ethyl - Moderate dose

    Drug: Alcohol, Ethyl · Other: Alcohol, Ethyl - placebo

Interventions

  • Randomized within-subjects design

    Also known as: Alcohol

  • OtherAlcohol, Ethyl - placebo

    Randomized within-subjects design

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Plasma lipopolysaccharide (pg/ml)

    Plasma concentration of lipopolysaccharide, measured in picograms/ml

    Time frame: 0-4 hours

  2. Plasma lipopolysaccharide binding protein (ng/ml)

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

    Time frame: 0-4 hours

  3. Soluble cluster of differentiation 14 (ng/ml)

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

    Time frame: 0-4 hours

  4. Soluble cluster of differentiation 163 (ng/ml)

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

    Time frame: 0-4 hours

Secondary outcomes

  1. Response time in ms

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

    Time frame: 0-4 hours

07

Study locations

1 site
  • Brown University
    Providence, Rhode Island 02912, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in Jun 2021, 32 months.

Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 32 months is above that.

Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2018
First posted
Mar 30, 2018
StartActual
Oct 1, 2018
Primary completionActual
Jun 18, 2021
CompletionActual
Jun 18, 2021
Last update
Jul 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03483389
Lead sponsor
Brown University
Responsible party
Mollie Monnig (Assistant Professor of Behavioral and Social Sciences, Brown University) — Principal investigator
First posted
Mar 30, 2018
Start date
Oct 1, 2018
Primary completion
Jun 18, 2021
Completion
Jun 18, 2021
Last update
Jul 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ethanol

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