Alcohol and Immune Response

NCT ID: NCT03483389

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-06-18

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Drinking Alcohol; Harmful Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Alcohol, placebo

Alcohol, ethyl - Placebo

Group Type EXPERIMENTAL

Alcohol, Ethyl

Intervention Type DRUG

Randomized within-subjects design

Alcohol, Ethyl - placebo

Intervention Type OTHER

Randomized within-subjects design

Alcohol, low dose

Alcohol, ethyl - Low dose

Group Type EXPERIMENTAL

Alcohol, Ethyl

Intervention Type DRUG

Randomized within-subjects design

Alcohol, Ethyl - placebo

Intervention Type OTHER

Randomized within-subjects design

Alcohol, moderate dose

Alcohol, ethyl - Moderate dose

Group Type EXPERIMENTAL

Alcohol, Ethyl

Intervention Type DRUG

Randomized within-subjects design

Alcohol, Ethyl - placebo

Intervention Type OTHER

Randomized within-subjects design

Interventions

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Alcohol, Ethyl

Randomized within-subjects design

Intervention Type DRUG

Alcohol, Ethyl - placebo

Randomized within-subjects design

Intervention Type OTHER

Other Intervention Names

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Alcohol Placebo

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brown University

OTHER

Sponsor Role lead

Responsible Party

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Mollie Monnig

Assistant Professor of Behavioral and Social Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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1710001919

Identifier Type: -

Identifier Source: org_study_id

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