Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

July 18, 2022 updated by: Mollie Monnig, Brown University
This study examines the effects of moderate alcohol intake on the brain, the immune system, and cognition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study involves a within-subjects, pre/post design to assess the effects of a moderate dose of alcohol on immune biomarkers, neurobiological measures, and cognitive functioning. The study recruits healthy adults (ages 21-45) from the community to complete the experimental protocol. Participants complete magnetic resonance imaging scans, blood sample collection, and cognitive testing in the context of alcohol consumption.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 21-45 years
  • Able to speak and read English at least at 8th grade level
  • Moderate self-reported alcohol use in the past year
  • Body mass index in normal to overweight range
  • Right-handed

Exclusion Criteria:

  • History of heavy drinking
  • Currently seeking alcohol or drug treatment
  • Chronic disease requiring use of medication
  • Recent antibiotic or probiotic use
  • Chronic daily use of NSAIDs
  • Chronic GI disorder
  • Use of illicit drugs
  • Major psychiatric disorder or suicidality
  • Fainting, weakness, infection, excessive bruising, or distress resulting from standard blood draw
  • Safety contraindication for MRI scan
  • Inability to abstain from use of tobacco products prior to or during study
  • Inability to abstain from use of cannabis prior to or during study
  • Pregnant, nursing, or may become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune biomarkers
Time Frame: 1-3 hours after alcohol intake
1-3 hours after alcohol intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Institute of General Medical Sciences (NIGMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

September 28, 2017

Study Completion (Actual)

September 28, 2017

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608001583
  • P20GM103645 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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