Acute Neuroimmune Effects of Alcohol Using Free Water Ima... | NCT03370783

Studies
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

NCT03370783

Sponsor

Brown University

Status

Completed

Last Update Posted

Jul 20, 2022Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Alcohol Drinking

Interventions

Ethanol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P20GM103645	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2017Actual

Primary Completion Date

Sep 28, 2017Actual

Completion Date

Sep 28, 2017Actual

First Submitted Date

Dec 7, 2017

First Submission Date that Met QC Criteria

Dec 7, 2017

First Posted Date

Dec 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2022

Last Update Posted Date

Jul 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mollie Monnig, Assistant Professor of Behavioral and Social Sciences, Brown UniversityPrincipal Investigator

Lead Sponsor

Brown UniversityOTHER

Collaborators

Name	Class
National Institute of General Medical Sciences (NIGMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Name	Type	Description	Arm Group Labels	Other Names
Ethanol	Drug	Moderate alcohol consumption

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brown University		Providence	Rhode Island	02912	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	May 31, 2017	Mar 24, 2020	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000428	Alcohol Drinking

Ancestor Terms

ID	Term
D004327	Drinking Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000431	Ethanol

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided