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Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ethanol
Sponsored by
Brown University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Drinking

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown University

Outcomes

Primary Outcome Measures

Immune biomarkers

Secondary Outcome Measures

Full Information

First Posted
December 7, 2017
Last Updated
July 18, 2022
Sponsor
Brown University
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03370783
Brief Title
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
Official Title
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute of General Medical Sciences (NIGMS)

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 examines the effects of moderate alcohol intake on the brain, the immune system, and cognition.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
Moderate alcohol consumption
Primary Outcome Measure Information:
Title
Immune biomarkers
Time Frame
1-3 hours after alcohol intake

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

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