NCT03483389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.7 years

First QC Date

March 6, 2018

Last Update Submit

July 26, 2021

Conditions

Alcohol DrinkingAlcohol; Harmful Use

Outcome Measures

Primary Outcomes (4)

  • Plasma lipopolysaccharide (pg/ml)

    Plasma concentration of lipopolysaccharide, measured in picograms/ml

    0-4 hours

  • Plasma lipopolysaccharide binding protein (ng/ml)

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

    0-4 hours

  • Soluble cluster of differentiation 14 (ng/ml)

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

    0-4 hours

  • Soluble cluster of differentiation 163 (ng/ml)

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

    0-4 hours

Secondary Outcomes (1)

  • Response time in ms

    0-4 hours

Study Arms (3)

Alcohol, placebo

EXPERIMENTAL

Alcohol, ethyl - Placebo

Drug: Alcohol, EthylOther: Alcohol, Ethyl - placebo

Alcohol, low dose

EXPERIMENTAL

Alcohol, ethyl - Low dose

Drug: Alcohol, EthylOther: Alcohol, Ethyl - placebo

Alcohol, moderate dose

EXPERIMENTAL

Alcohol, ethyl - Moderate dose

Drug: Alcohol, EthylOther: Alcohol, Ethyl - placebo

Interventions

Alcohol, EthylDRUG

Randomized within-subjects design

Also known as: Alcohol
Alcohol, low doseAlcohol, moderate doseAlcohol, placebo
Alcohol, Ethyl - placeboOTHER

Randomized within-subjects design

Also known as: Placebo
Alcohol, low doseAlcohol, moderate doseAlcohol, placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Behavioral and Social Sciences

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 30, 2018

Study Start

October 1, 2018

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

US(1)