Ketone Ester for Alcoholism
Trial Summary
What is the purpose of this trial?
The purpose of this research is to study how a nutritional ketone ester may effect brain function and alcohol consumption in regular alcohol users. The study will see how the brain responds, once after drinking the ketone ester and once after drinking a "placebo", which will look and taste the same as the ketone ester drink. Metabolic ketosis induced by a ketogenic diet has been previously shown to elevate brain ketone bodies and reduce alcohol withdrawal symptoms in humans with AUD, and reduce alcohol consumption in alcohol-dependent rats. The study investigates whether metabolic ketosis induced by a one-dose nutritional ketone ester (KE) reduces brain reactivity to alcohol cues (fMRI), alcohol craving and alcohol consumption in humans with AUD, and if KE elevates ketone bodies using proton spectroscopy. This study uses a double blind, random ordered, 2-way crossover design in n=20 non-treatment seeking AUD who come in on two separate testing days: on one testing day the participants consume KE ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate), and on another testing day a drink with isocaloric dextrose (DEXT), after which participants are scanned for 1H-MRS and fMRI and complete an alcohol consumption paradigm each day after scanning.
Will I have to stop taking my current medications?
The trial requires participants to refrain from using psychoactive medications or any medication that may affect study results within 24 hours of MRI procedures. If you are taking such medications, you may need to stop or adjust them before participating.
What data supports the effectiveness of the drug (R)-3-hydroxybutyl (R)-3-hydroxybutyrate for alcoholism?
Is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate safe for human use?
Research shows that (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, also known as ketone ester, is generally safe for humans. In studies with healthy adults, it was well-tolerated, though some people experienced mild stomach issues at high doses. Animal studies also support its safety, with no significant harmful effects observed even at high intake levels.13678
How is the ketone ester treatment for alcoholism different from other treatments?
The ketone ester treatment for alcoholism is unique because it uses a compound that elevates blood ketone levels, which may help improve cognitive and physical performance, unlike traditional treatments that focus on reducing alcohol cravings or blocking alcohol's effects. This treatment is administered as a meal replacement drink, offering a novel approach compared to standard medications.127910
Eligibility Criteria
This trial is for adults aged 21-65 with Alcohol Use Disorder (AUD) who consume at least 15 alcoholic drinks weekly and are not seeking treatment. Participants must be willing to use reliable birth control if applicable, have no major psychiatric disorders requiring hospitalization or daily medication, and cannot have conditions like epilepsy, diabetes, liver disease, or a history of severe head trauma.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Testing Day 1
Participants consume a ketone ester drink, undergo MRI scanning, and participate in an alcohol consumption paradigm
Testing Day 2
Participants consume a placebo drink, undergo MRI scanning, and participate in an alcohol consumption paradigm
Follow-up
Participants are monitored for safety and effectiveness after the testing days
Treatment Details
Interventions
- (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (Other)