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Ketone Ester for Alcoholism
Phase 2 & 3
Recruiting
Led By Corinde E Wiers, Ph.D.
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants report average weekly ethanol consumption of at least 15 standard drinks weekly over the past month prior to consent (self-report) (for AUD group)
Age 21 years to 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights
Study Summary
This trial will study the effects of a nutritional supplement, ketone ester, on the brain and heart function of people with and without alcohol use disorder.
Who is the study for?
This trial is for adults aged 21-65, with or without alcohol use disorder, who can commit to the study and avoid alcohol for 24 hours before sessions. Excluded are those with seizures, high BMI (>35), metal implants incompatible with MRI/PET scans, vision issues not corrected by glasses, serious medical/psychological conditions, HIV positive individuals, pregnant/breastfeeding women, and certain psychiatric diagnoses.Check my eligibility
What is being tested?
The study tests how a nutritional supplement 'ketone ester' affects brain and heart function and alcohol consumption in people with alcohol use disorder compared to healthy volunteers. It involves taking a single dose of ketone ester or placebo followed by PET/CT scans using FDG.See study design
What are the potential side effects?
Potential side effects from the ketone ester are not detailed but may include gastrointestinal discomfort based on similar supplements. The FDG PET/CT scan is generally safe but may cause allergic reactions or exposure to low levels of radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have consumed an average of 15 or more drinks per week in the last month.
Select...
I am between 21 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FDG uptake (CMRg) in the brain and heart
Secondary outcome measures
Amount of BHB (beta-hydroxybutyrate) (mmol/L)
Amount of FDG uptake (CMRg)
Amount of blood glucose (mmol/L or mg/dl)
Side effects data
From 2014 Phase 2 trial • 26 Patients • NCT0096380711%
Death
11%
Dyspnea
11%
Neutropenic Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Echocardiogram + PET FDG scanning visit.Experimental Treatment1 Intervention
Subjects will complete a echocardiogram + PET scanning visit. 2-Deoxy-2-[18F] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.
Group II: Ketone ester + echocardiogram + PET FDG scanning visit.Active Control2 Interventions
Subjects will drink single dose of ketone ester 1.9 kcal/kg + echocardiogram + PET scanning visit. Dietary Supplement: Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (R)-3-hydroxybutyrate (commercially available as DeltaG, (TdeltaS, Orlando, FL). 2-Deoxy-2-[18F] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FDG
2014
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,189 Total Patients Enrolled
26 Trials studying Alcoholism
3,630 Patients Enrolled for Alcoholism
Corinde E Wiers, Ph.D.Principal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Alcoholism
70 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had a severe head injury with loss of consciousness, skull fracture, or bleeding.I have consumed an average of 15 or more drinks per week in the last month.I can avoid taking certain medications like painkillers or antibiotics 24 hours before a PET/CT scan.I have a major psychiatric disorder that needed hospital care or daily meds for over a month last year.I have a history of seizures.I am not pregnant or breastfeeding, and I can take a pregnancy test if needed.I am between 21 and 65 years old.I have had a stroke or suffer from muscle stiffness due to a stroke.
Research Study Groups:
This trial has the following groups:- Group 1: Echocardiogram + PET FDG scanning visit.
- Group 2: Ketone ester + echocardiogram + PET FDG scanning visit.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are they looking for more participants in this trial right now?
"The answer is affirmative, this trial mentioned on clinicaltrials.gov is recruiting patients as we speak. This research was originally posted on November 1st 2021 and updated recently on July 18th 2022. 20 individuals will be chosen for the study from a single location."
Answered by AI
Might I be a candidate for this clinical trial?
"This clinical trial is looking for 20 participants who drink alcohol regularly. Participants must be between the ages of 21 and 65 and meet the following criteria: They must agree to not consume alcohol for 24 hours prior to each laboratory session, they must report drinking at least 15 standard drinks per week in the month leading up to consenting to participate, they must have had their last drink within a week of PET visits, they must consider alcohol their preferred drug, and they must meet DSM-5 criteria for current AUD."
Answered by AI
Does this clinical trial have an age limit?
"The age range for this particular trial is 21 to 65. By comparison, there are 34 trials available for minors and 254 for seniors."
Answered by AI
How many patients will this trial be testing?
"That is correct. According to the clinicaltrials.gov website, this study is still recruiting patients. 20 individuals are needed for the trial which will occur at 1 location; the posting went up on November first 2021 and was last edited July 18th, 2022."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
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