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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, 2 FDG PET/CT scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.

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.

What data supports the effectiveness of the drug Kenetik for treating alcoholism?

Research shows that ketamine, which may be similar to Kenetik, can reduce alcohol consumption in alcohol-preferring rats and create beneficial conditions for psychotherapy in humans, suggesting potential effectiveness in treating alcoholism. ^{1 2 3 4 5}

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 related, showed that combining it with alcohol in adolescent rats led to increased neurotoxicity (harm to the nervous system). This suggests caution when using similar treatments. ^{6 7 8 9 10}

Research Team

Corinde Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Experience in using ketamine preparations in the psychotherapy of alcoholism]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Inpatient treatment of alcoholism: a behavioral approach. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[DGRW update: alcohol addiction]. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Long term outcome for alcoholic patients treated in a hospital based unit. [2006]

5. Netherlands pubmed.ncbi.nlm.nih.gov

mTOR activation is required for the anti-alcohol effect of ketamine, but not memantine, in alcohol-preferring rats. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adjunct Ketamine Use in the Management of Severe Ethanol Withdrawal. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Alcohol aggravates ketamine-induced behavioral, morphological and neurochemical alterations in adolescent rats: The involvement of CREB-related pathways. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A prospective, open-label trial of ondansetron in adolescents with alcohol dependence. [2018]

9. England pubmed.ncbi.nlm.nih.gov

A pilot study of full-dose ondansetron to treat heavy-drinking men withdrawing from alcohol in Brazil. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Drug adjuncts for treating alcohol dependence. [2019]