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NCT03370783 Clinical Trial

Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

Alcohol Drinking Clinical Trial

Official title:
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03370783
Other study ID # 1608001583
Secondary ID P20GM103645
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2017
Est. completion date September 28, 2017

Study information
Verified date July 2022
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date September 28, 2017
Est. primary completion date September 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ethanol
Moderate alcohol consumption

Locations
Country Name City State
United States Brown University Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
Brown University National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune biomarkers 1-3 hours after alcohol intake
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