Ketone Supplementation for Alcohol Withdrawal

Enrolling by invitation at 1 trial location

Overseen By Timothy S Pond, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Pennsylvania

Must not be taking: Benzodiazepines, Opioids

Disqualifiers: GI disease, Pregnancy, Others

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

Compensation: Varies

Number of Visits: 1

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a ketone supplement called Kenetik can alleviate alcohol withdrawal symptoms, comparing it to a placebo (a drink with no active ingredients). Participants will receive either Kenetik or the placebo drink three times a day for five days during their treatment at the Caron Treatment Center. Suitable candidates for this trial include individuals with alcohol use disorder (a pattern of drinking that involves problems controlling alcohol use) who are currently receiving treatment for alcohol withdrawal. As a Phase 2, Phase 3 trial, this research measures Kenetik's effectiveness in an initial group and represents the final step before FDA approval, offering a chance to contribute to significant advancements in treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are experiencing significant withdrawal from substances like benzodiazepines or opioids, you may not be eligible to participate.

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

Research shows that ketone supplements like Kenetik might help with alcohol withdrawal. Studies have found that both a high-fat ketogenic diet and ketone supplements can lessen alcohol cravings, reduce drinking, and ease withdrawal symptoms. This suggests Kenetik could be beneficial for these issues.

Regarding safety, ketone supplements are usually well-tolerated. Research has not identified any serious side effects. However, some people might experience mild stomach problems, such as nausea or diarrhea, when taking ketone supplements. While Kenetik is generally safe for most people, it might cause minor discomfort for some. Always consult a healthcare provider about possible side effects before joining a trial. ^{1 2 3 4 5}

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

Most treatments for alcohol withdrawal focus on managing symptoms with medications like benzodiazepines. But Kenetik offers a different approach by using a ketone supplement that provides an alternative energy source for the brain. This is especially important because during alcohol withdrawal, the brain's energy metabolism is disrupted. Kenetik's ketone supplement is designed to stabilize brain function more quickly and potentially reduce withdrawal symptoms without the sedative effects commonly associated with standard treatments. Researchers are excited because this could lead to a safer and more effective way to support recovery during the critical early days of withdrawal.

What evidence suggests that this treatment might be an effective treatment for alcohol withdrawal?

Research has shown that ketone supplements, such as Kenetik, might help reduce symptoms of alcohol withdrawal. Studies have found that these supplements can lower cravings and decrease alcohol use. They also alleviate withdrawal symptoms like anxiety and seizures. Some animal studies demonstrated that a ketogenic diet and ketone supplements improved mood and reduced behaviors related to withdrawal. In this trial, participants will receive either the ketone supplement Kenetik or a placebo beverage to evaluate its effectiveness in managing alcohol withdrawal symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Corinde E Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals undergoing clinical treatment for acute alcohol withdrawal. Participants should be experiencing symptoms of alcohol withdrawal and are currently in a treatment program.

Inclusion Criteria

I am diagnosed with alcohol use disorder and am getting treatment for withdrawal.

Willingness to provide signed, informed consent and commit to completing the procedures in the study

Exclusion Criteria

Currently pregnant or lactating, based on urine pregnancy test and clinical exam

Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study

I don't have GI, liver, or other diseases that could affect taking a Ketone Supplement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 days

1 visit (in-person)

Treatment

Participants receive either the ketone supplement or placebo three times daily for 5 days during inpatient alcohol withdrawal management

5 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kenetik

Trial Overview The study aims to compare the effects of Kenetik, a ketone supplement, with an inactive placebo beverage on managing symptoms during the first 5 days of alcohol withdrawal treatment.

How Is the Trial Designed?

Group I: Ketone Supplement Active Control 1 Intervention

Ketone Supplement drink with 10 g ketones three times daily for five days.

Group II: Placebo Beverage Placebo Group 1 Intervention

Matching Placebo drink three times daily for five days

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study involving 33 inpatients with alcohol use disorder, those on a ketogenic diet (KD) required fewer benzodiazepines during detoxification compared to those on a standard American diet, suggesting that KD may help reduce withdrawal severity.

The KD not only altered brain metabolism by increasing ketones and glutamate while lowering neuroinflammatory markers but also showed potential in reducing alcohol cravings and consumption, as evidenced by a rat model of alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet reduces alcohol withdrawal symptoms in humans and alcohol intake in rodents. Wiers, CE., Vendruscolo, LF., van der Veen, JW., et al.[2022]

In a study with 10 healthy participants, ketone supplements (KS) significantly reduced breath alcohol concentration (BrAC) and blood alcohol levels (BAL) after alcohol consumption, indicating a potential to lessen the intoxicating effects of alcohol.

In a parallel study with rats, KS also lowered BAL more effectively than water or a sweetener, suggesting that ketones may alter both physiological and subjective responses to alcohol, making them a promising intervention for alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketone supplementation dampens subjective and objective responses to alcohol in rats and humans. Li, X., Shi, Z., Todaro, D., et al.[2023]

A preclinical study using male Sprague Dawley rats indicated that a ketogenic diet significantly reduced symptoms of alcohol withdrawal, such as rigidity and irritability, after alcohol administration.

This research suggests that a ketogenic diet could be a novel and effective strategy for managing alcohol withdrawal symptoms during detoxification in humans, addressing a critical gap in current treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic Diet Suppresses Alcohol Withdrawal Syndrome in Rats. Dencker, D., Molander, A., Thomsen, M., et al.[2019]

Nutritional ketosis, achieved through a ketogenic diet or ketone ester ingestion, may help reduce withdrawal symptoms and cravings in individuals with alcohol use disorder (AUD), based on both preclinical and clinical studies.

The mechanism behind this effect involves a shift in metabolism from glucose to acetate during alcohol intoxication, and a decline in acetate levels during withdrawal, which nutritional ketosis can help counteract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Ketosis as a Potential Treatment for Alcohol Use Disorder. Mahajan, VR., Elvig, SK., Vendruscolo, LF., et al.[2022]

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. 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 Clinical Institute Withdrawal Assessment Alcohol Scale Revised ...

3. 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.

4. nature.com nature.com/articles/s41598-024-55310-3

Nutritional ketosis as treatment for alcohol withdrawal ... Both KD and KE rescued anhedonia for up to three weeks of abstinence. KD mice showed higher latency to first immobility in the tail suspension ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7914216/

Effects of ketogenic diet and ketone monoester supplement on ... The regular diet with ketone monoester was sufficient to reduce handling-induced convulsions and anxiety-like behaviors in early withdrawal.

6. withpower.com withpower.com/trial/phase-2-and-3-ketosis-2024-e7290

Ketone Supplementation for Alcohol Withdrawal What is the purpose of this trial? The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on ...

7. 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, ... PDF | Background Previous preclinical and human studies have shown that a high-fat ketogenic diet and ketone supplements (KS) are efficacious in.