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Could a ketone drink ease alcohol withdrawal?

NCT ID NCT06559995

Symptom relief Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether a ketone supplement drink can reduce alcohol withdrawal symptoms in 30 adults with moderate to severe alcohol use disorder. Participants will receive either the ketone drink or a placebo for 4 days during inpatient detox. The main goal is to see if the ketone drink lowers the amount of benzodiazepine medication needed to manage withdrawal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketone supplement (D-beta-hydroxybutyric acid and R-1,3 butanediol)
What this could lead to
If it works, this could offer a new way to manage alcohol withdrawal symptoms and reduce reliance on standard sedative medications.
What could go wrong
This is an early combined Phase 2/3 trial with only 30 participants, so results may not apply broadly. The supplement may not outperform placebo, and side effects are not yet well understood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to communicate English and provide written informed consent 2. Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD 3. Minimum 3-year history of heavy drinking (self-report). 4. Presence of alcohol withdrawal (DSM-5) Exclusion Criteria: 1. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures. 2. Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history and physical exam. 3. Clinically significant laboratory findings that could affect brain function (e.g., HIV+) 4. Head trauma with loss of consciousness for more than 30 minutes, 5. Pregnant or breast-feeding 6. BMI greater than 35 7. Self-reported claustrophobia 8. Contraindications to MRI (e.g., metal in the body that cannot be removed). 9. Current, gastrointestinal (GI), liver or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician. 10. Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan. 11. Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcohol withdrawal Ketosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder Alcohol withdrawal Ketosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Studies of Addiction

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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