Kenotic for Alcoholism

(KABA Trial)

Overseen By Timothy Pond, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Pennsylvania

Must not be taking: Psychoactive medications

Disqualifiers: Major psychiatric disorder, Alcohol withdrawal, Physical disease, GI diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Kenetik, a ketone supplement, to determine if it can improve brain function and reduce alcohol consumption in individuals with alcohol use disorder. Participants will compare Kenetik with a placebo to assess any immediate benefits. The trial includes MRI and PET/CT scans and controlled alcohol consumption in a lab setting. It suits those who have consumed at least 15 drinks weekly over the past month and are not currently seeking treatment for alcohol use disorder. As a Phase 2 and Phase 3 trial, this research measures Kenetik's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that participants do not use psychoactive medications or any medications that might affect the study results. If you are taking such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketone supplements like Kenetik are generally safe and well-tolerated. One study found that free D-BHB, an ingredient in Kenetik, was safe and did not cause major side effects. This supplement helps the body enter ketosis, a state where it burns fat for energy.

Although specific safety data for Kenetik in humans is not yet available, similar ketone supplements have been used without significant issues. More research is needed to confirm its safety when taken with alcohol, but early results appear promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Unlike the standard treatments for alcoholism, which often include medications like naltrexone, acamprosate, and disulfiram, Kenetik offers a unique approach by using ketones. Kenetik is a ketone supplement containing D-beta-hydroxybutyric acid and R-1,3 butanediol, which may help modulate brain energy metabolism. This is different because it focuses on altering brain chemistry through ketone supplementation rather than targeting neurotransmitter systems directly. Researchers are excited about this novel angle as it could offer a new pathway for reducing alcohol cravings and consumption, potentially benefiting those for whom traditional treatments are ineffective.

What evidence suggests that Kenetik might be an effective treatment for alcoholism?

Research has shown that ketone supplements like Kenetik, which participants in this trial may receive, can help reduce the urge to drink alcohol and the amount consumed. Individuals who have tried a high-fat ketogenic diet and ketone supplements have experienced fewer signs of alcohol withdrawal. In another study, Kenetik lessened both the feelings and physical signs of wanting alcohol. Evidence from research involving both rats and humans supports these findings, showing that ketone supplements can ease alcohol withdrawal symptoms. Overall, these studies suggest Kenetik may be a promising tool for managing alcohol use disorder. ^{1 4 6 7 8}

Who Is on the Research Team?

Corinde Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals with alcohol use disorder who are interested in how a nutritional ketone supplement might affect their brain function and drinking behavior. Participants will undergo scans and lab sessions involving alcohol consumption.

Inclusion Criteria

I am between 21 and 65 years old.

Not seeking treatment for AUD (self-report)

Able to provide written informed consent

Exclusion Criteria

I am claustrophobic.

Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol, Marijuana, and nicotine use disorders) that required hospitalization or daily medication in the past year

Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Alcohol Bar Lab

Participants undergo alcohol bar lab sessions to study the effects of Kenetik on alcohol consumption

2 visits, each approximately 5 hours

2 visits (in-person)

MRI Scan

Participants receive MRI scans to study brain function with Kenetik and placebo

2 visits, each approximately 2 hours

2 visits (in-person)

PET Scan

Participants undergo PET scans to evaluate brain energetics with Kenetik and placebo

2 visits, each approximately 3 hours

2 visits (in-person)

Follow-up

Participants are monitored for any side effects after each lab visit

1 day after each lab visit

Phone call follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Kenetik

Trial Overview The study tests the effects of Kenetik, a ketone supplement, versus a placebo on brain energy and response to alcohol. It involves MRI and PET/CT scans, plus controlled alcohol intake in a bar lab setting, with treatments given randomly.

How Is the Trial Designed?

Group I: Alcohol beverage Experimental Treatment 2 Interventions

The alcoholic beverage will be created by using a standard dose of 0.5g/kg 0.43 g/kg for men and women respectively (50% vodka), calculated to achieve a BrAC of about 0.050%. The alcoholic beverage will be given once at bar lab 1 and again at bar lab 2.

Group II: Ketone Supplement, Kenetik Active Control 3 Interventions

Kenetik: Ketone Drink supplement containing D-beta-hydroxybutyric acid and R-1,3 butanediol. D-beta-hydroxybutyric acid (C4H8O3) and 1,3 butanediol (C4H10O2). We will give 25 g of ketones 3 times. Once at an MRI visit, once at an FDG PET/CT scan visit, and once at an alcohol bar lab visit.

Group III: Placebo Beverage Placebo Group 3 Interventions

Taste-matched placebo beverage is given 3 times. Once at an MRI visit, once at an FDG PET/CT scan visit, and once at an alcohol bar lab visit.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The FDA has approved three main drugs for treating alcoholism: disulfiram, naltrexone, and acamprosate, which are specifically designed to help individuals with alcohol dependence.

There is ongoing research into other medications, such as nalmafene, topiramate, and ondansetron, which are being used off-label, indicating a potential for new treatment options as our understanding of alcoholism improves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug adjuncts for treating alcohol dependence. Collins, GB., McAllister, MS., Adury, K.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06559995

Effects of Ketone Supplementation on Alcohol Withdrawal ... The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10901540/

Ketone Supplementation Dampens Subjective and ... A high-fat ketogenic diet and ketone supplements (KS) are efficacious in reducing alcohol craving, alcohol consumption, and signs of alcohol withdrawal.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06173973

Effects of Ketone Supplementation on Acute Alcohol ... To examine the effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg), while ...

4. researchgate.net researchgate.net/publication/377978898_Ketone_supplementation_dampens_subjective_and_objective_responses_to_alcohol_evidence_from_a_preclinical_rat_study_and_a_randomized_cross-over_trial_in_healthy_volunteers

Evidence From a Preclinical Rat Study and a Randomized, ... Background We previously showed that ketogenic diet (KD) was effective in curbing alcohol withdrawal and craving in individuals with alcohol use disorder (AUD).

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06815237?draw=2&rank=1

Effects Ketone Supplement and Alcohol on Brain Metabolism The research study is being conducted to better understand the effects of ketones and alcohol on brain functioning and brain metabolism.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11009516/

Evaluation of the safety and tolerability of exogenous ketosis ... Free D-BHB was a safe and well-tolerated intervention for inducing sustained exogenous ketosis. Being bioidentical, salt-free and lacking intermediate ...

7. withpower.com withpower.com/trial/kenotic-for-alcoholism-9b3a1

Kenotic for Alcoholism · Info for Participants Is Kenotic (or Kenetik) safe for humans? There is no specific safety data available for Kenotic or Kenetik in humans, but a study on ketamine, which may be ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224016603

1,3-butanediol administration as an alternative strategy to ... The alcohol 1,3-butanediol (BD) is a promising molecule for its ability to induce ketosis, but its effects on brain have been investigated so far only in ...