Ketone Supplementation for Alcohol Withdrawal

Recruiting 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

50 Participants Needed

Trial Summary

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 alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the Caron Treatment Center.

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.

What data supports the effectiveness of the treatment Kenetik for alcohol withdrawal?

Research suggests that a ketogenic diet, which increases ketone levels in the body, can reduce alcohol withdrawal symptoms and cravings. This is because it shifts the brain's energy source from glucose to ketones, which may help manage withdrawal symptoms and reduce alcohol consumption. ^{1 2 3 4 5}

Is ketone supplementation safe for humans?

Research shows that ketone supplements have been used safely in humans to reduce alcohol craving and withdrawal symptoms. In a study, healthy participants who took a ketone supplement before consuming alcohol experienced reduced alcohol effects without any reported safety issues. ^{1 2 4 6 7}

How is the treatment Kenetik different from other treatments for alcohol withdrawal?

Kenetik, a ketone supplement, is unique because it uses nutritional ketosis to help manage alcohol withdrawal symptoms by shifting the brain's energy source from glucose to ketones, potentially reducing cravings and withdrawal severity. This approach is different from traditional treatments that often rely on medications like benzodiazepines. ^{2 3 4 5 6}

Research Team

Corinde E Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

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

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

Ketogenic diet reduces a neurobiological craving signature in alcohol use disorder. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Ketosis as a Potential Treatment for Alcohol Use Disorder. [2022]

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

Ketogenic diet reduces alcohol withdrawal symptoms in humans and alcohol intake in rodents. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Ketogenic Diet Suppresses Alcohol Withdrawal Syndrome in Rats. [2019]

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

Ketone supplementation dampens subjective and objective responses to alcohol in rats and humans. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

Two models of ethanol withdrawal kindling. [2006]