NCT03370783

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

December 7, 2017

Last Update Submit

July 18, 2022

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

  • Immune biomarkers

    1-3 hours after alcohol intake

Interventions

EthanolDRUG

Moderate alcohol consumption

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Behavioral and Social Sciences

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 12, 2017

Study Start

March 31, 2017

Primary Completion

September 28, 2017

Study Completion

September 28, 2017

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)