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Oral Alcohol Challenge for Alcohol Consumption

Phase < 1
Waitlist Available
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. the total scan time for each imaging scan is 120 minutes long.
Awards & highlights

Study Summary

This trial uses PET scans to study how alcohol affects the brain's immune response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. the total scan time for each imaging scan is 120 minutes long.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. the total scan time for each imaging scan is 120 minutes long. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in [11C]PBR28 Distribution Volume After Alcohol Challenge.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Moderate DrinkersExperimental Treatment1 Intervention
Aim 1: A baseline PET scan with [11C]PBR28, a TSPO-specific radioligand, will be conducted with moderate drinkers. Next, subjects will drink a fixed alcohol dose, followed a post-alcohol [11C]PBR28 PET scan timed to capture acute neuroimmune response. [11C]PBR28 distribution volumes (VT), which are proportional to TSPO number, will be measured throughout the brain. We will test the hypothesis that acute alcohol robustly increases [11C]PBR28 VT, consistent with microglial activation. The percent change in [11C]PBR28 VT (ΔVT) from baseline will quantify the magnitude of neuroimmune response.
Group II: Alcohol Use Disorder (AUD)Experimental Treatment1 Intervention
Aim 2: AUD subjects will participate in the study design described in Aim 1 (a baseline [11C]PBR28 PET scan, drink a fixed alcohol dose, followed by a post-alcohol [11C]PBR28 PET scans). The magnitude of neuroimmune response, quantified by ΔVT, will be compared between moderate drinkers and individuals with AUD to test the hypothesis that the neuroimmune response to alcohol is greater in those with AUD compared to moderate drinkers, consistent with the concept of alcohol 'priming microglia'.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Alcohol Challenge
2019
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,497 Total Patients Enrolled
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,654 Total Patients Enrolled
Ansel T Hillmer, Ph.D.Principal InvestigatorYale University
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Oral Alcohol Challenge (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04251221 — Phase < 1
Alcohol Consumption Research Study Groups: Alcohol Use Disorder (AUD), Moderate Drinkers
Alcohol Consumption Clinical Trial 2023: Oral Alcohol Challenge Highlights & Side Effects. Trial Name: NCT04251221 — Phase < 1
Oral Alcohol Challenge (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04251221 — Phase < 1

Frequently Asked Questions

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

Are individuals currently being recruited to participate in this research effort?

"At this time, there is no active recruitment for this clinical trial. Having gone live on June 1st 2019 and most recently amended December 16th 2021, it appears that the study has since concluded its data collection period. Fortunately, 245 trials related to alcohol drinking are actively recruiting patients and 38 Oral Alcohol Challenge studies are currently enrolling volunteers."

Answered by AI

How many individuals have been registered to participate in this trial?

"At present, this clinical trial is no longer accepting patients. The study was first launched on June 1st 2019 and saw its most recent update on December 16th 2021. If you are looking for other studies related to alcohol drinking, there are currently 245 active trials with 38 of them focused specifically on Oral Alcohol Challenge enrollment."

Answered by AI

What primary purpose does Oral Alcohol Challenge serve?

"Oral Alcohol Challenge is the primary treatment for hypertrophic cardiomyopathy and can be a useful intervention for communicable diseases, ethylene glycol poisoning, and as an antiseptic on skin."

Answered by AI

Does the trial enrollment age encompass individuals aged 60 and below?

"According to the study requirements, only those individuals aged between 21 and 30 are eligible for enrollment. Currently, there are 26 studies where participants must be below 18 years old and 176 trials with applicants over 65."

Answered by AI

What criteria has been established for prospective participants of this trial?

"This study is seeking approximately 60 participants who demonstrate an inclination towards alcohol consumption and are within the ages of 21-30."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Measuring the Neuroimmune Response to Alcohol
Ansel Hillmer 2019. "Measuring the Neuroimmune Response to Alcohol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04251221.
~2 spots leftby Apr 2025
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