Alcohol DrinkingNCT03370783
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
A study testing Ethanol in people with Alcohol Drinking, run by Brown University at 1 site in United States.
Trial summary
This study examines the effects of moderate alcohol intake on the brain, the immune system, and cognition. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Ethanol
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the effects of moderate alcohol intake on the brain, the immune system, and cognition.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Ethanol
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
Moderate alcohol consumption
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune biomarkers
Measured: 1-3 hours after alcohol intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start31 Mar 2017
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Mollie Monnig, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370783
- Sponsor's protocol ID
- 1608001583
- Other IDs
- P20GM103645
- Status last verified
- Jul 2022
- First submitted
- 7 Dec 2017
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
- ClinicalTrials.gov ID
- NCT03370783
- Acronym / sponsor ID
- 1608001583
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolModerate alcohol consumption | Drug | – |
Primary outcome
Immune biomarkers
Time frame: 1-3 hours after alcohol intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol in people with Alcohol Drinking, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune biomarkers (time frame: 1-3 hours after alcohol intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.