Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

NCT ID: NCT03370783

Last Updated: 2022-07-20

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-09-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Interventions

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Ethanol

Moderate alcohol consumption

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

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

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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P20GM103645

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1608001583

Identifier Type: -

Identifier Source: org_study_id

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