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PET Scan for Alcohol-Induced Brain Changes

Phase < 1
Recruiting
Led By Ansel T Hillmer, Ph.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women, aged 21-55 years
Men and women, aged 21-55 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and within 2 hours of challenge
Awards & highlights

Study Summary

This trial will test how effective a PET scan is in detecting changes in the brain caused by alcohol.

Who is the study for?
This trial is for men and women aged 21-55 who drink moderately but don't have an alcohol use disorder. They must be in good health, not pregnant or nursing, able to follow study instructions, and willing to avoid certain medications. People with substance abuse issues (except nicotine), medical conditions that make drinking unsafe, or those unable to abstain from alcohol before the study can't participate.Check my eligibility
What is being tested?
The study aims to observe how glutamate—a brain chemical—reacts when participants consume alcohol. This is done using PET scans after an 'alcohol challenge' to see changes in the brain's glutamate system.See study design
What are the potential side effects?
Since the intervention involves consuming alcohol, potential side effects include typical reactions such as dizziness, nausea, impaired coordination and judgment. The PET scan may involve exposure to radiation within safe limits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 55 years old.
Select...
I am between 21 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and within 2 hours of challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and within 2 hours of challenge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol-induced change in receptor availability

Side effects data

From 2017 Phase 2 trial • 17 Patients • NCT01779024
59%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Hyperhidrosis
12%
Memory impairment
12%
Dizziness
12%
Nausea
6%
Headache
6%
Feeling hot
6%
Flushing
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alcohol ChallengeExperimental Treatment1 Intervention
Alcohol Challenge, I.V. infusion, 60 mg/dL in 6% saline (v/v), Given once
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alcohol
2008
Completed Phase 3
~2000

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,507 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
796 Previous Clinical Trials
1,361,403 Total Patients Enrolled
Ansel T Hillmer, Ph.D.Principal InvestigatorYale University
1 Previous Clinical Trials
14 Total Patients Enrolled

Media Library

Alcohol Clinical Trial Eligibility Overview. Trial Name: NCT04159688 — Phase < 1
Alcohol Consumption Research Study Groups: Alcohol Challenge
Alcohol Consumption Clinical Trial 2023: Alcohol Highlights & Side Effects. Trial Name: NCT04159688 — Phase < 1
Alcohol 2023 Treatment Timeline for Medical Study. Trial Name: NCT04159688 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to enrollment at the present time?

"Affirmative, clinicaltrials.gov indicates that this trial is still in need of participants. It was initially published on March 1st 2020 and the details were last amended on October 9th 2022. A total of 20 patients are being accepted at a single medical centre."

Answered by AI

How many persons are participating in this clinical trial?

"Yes, according to the information provided on clinicaltrials.gov this medical trial is still open for recruitment. It was first announced on March 1st 2020 and has since been updated multiple times with its most recent revision being October 9th 2022. The research team requires 20 individuals at a single site in order to complete the study."

Answered by AI

Can individuals younger than 40 years old partake in this medical trial?

"This trial seeks to enrol patients aged between 21 and 55. There are 26 studies targeting minors, as well as 176 trials involving elderly people who meet the selection criteria."

Answered by AI

In which scenarios is Alcohol commonly utilized?

"Alcohol can be effectively used to manage obstructive hypertrophic cardiomyopathy, communicable diseases, and ethylene glycol."

Answered by AI

What are the eligibility requirements for enrollment in this experiment?

"This clinical trial is currently seeking 20 individuals over the age of 21 and under 55 that have a history of excessive alcohol consumption. In order to qualify, participants must be male or female between these ages."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
How old are they?
18 - 65
What site did they apply to?
Yale University
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby Dec 2025