Alcohol Use DisorderPhase 2/3KSAWNCT06559995
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
A Phase 2/3 study testing ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones, and magnetic resonance imaging session in people with Alcohol Use Disorder and Alcohol Withdrawal, run by University of Pennsylvania at 1 site in United States.
Trial summary
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 withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Withdrawal, Ketosis
- What is being tested?
- ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones, and magnetic resonance imaging session
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Dec 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to communicate English and provide written informed consent
- Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
- Minimum 3-year history of heavy drinking (self-report).
- Presence of alcohol withdrawal (DSM-5)
Who cannot join
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.
- 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.
- Clinically significant laboratory findings that could affect brain function (e.g., HIV+)
- Head trauma with loss of consciousness for more than 30 minutes,
- Pregnant or breast-feeding
- BMI greater than 35
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- Self-reported claustrophobia
- Contraindications to MRI (e.g., metal in the body that cannot be removed).
- 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.
- Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
- Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104
Timothy Pond, MPH, 215-746-1959, timpond@pennmedicine.upenn.edu
Corinde Wiers, Ph.D
About this study
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 withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center.
Read the detailed description
This is a 4-day randomized double-blinded intervention study of 30 treatment seeking adults with alcohol use disorder, who are receiving alcohol detoxification treatment at the Hospital of the University of Pennsylvania, Cedar Detox Center. Within 24 hours of admission to the inpatient unit, participants will be consented and randomized to receive 3x daily of 12g of KS (n=15; 1,3-butanediol and D-hydroxybutyric acid from Kenetik, VitaNav Inc., Washington D.C.) for 4 days or placebo beverage (n=15). Benzodiazepines and other "comfort" medications will be administered daily following the HUP Cedar withdrawal management protocol, with benzodiazepines administered based on withdrawal symptoms, monitored with the revised Clinical Institute Withdrawal Assessment for Alcohol. The revised Clinical Institute Withdrawal Assessment for Alcohol is given three or more times a day clinically to determine patient withdrawal levels and adjust medication dosages. Total daily maximum revised Clinical Institute Withdrawal Assessment for Alcohol scores, benzodiazepine dosage, and other "comfort" medications will be analyzed with a repeated measures design, with a binary factor for intervention, factor of time, and intervention by time interaction. Daily mood questions and alcohol craving questions will assess differences between treatment groups. After 4 days of study intervention, all participants will undergo an approximately 1.5-hr. magnetic resonance imaging session.
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal, Ketosis
- Being tested
- ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,, magnetic resonance imaging session, Placebo beverage
- Keywords
- Alcohol Use Disorder, Alcohol Withdrawal, ketosis, Ketone Supplement
- Medical subject headings
- Alcoholism, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,Dietary supplement
Also called Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.
ketone supplement
magnetic resonance imaging sessionDiagnostic test
Also called MRI
1.5 hour magnetic resonance imaging session
Placebo beverageDietary supplement
Also called Placebo
Placebo beverage, visually matched, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.
| Study group | Role | What they receive |
|---|---|---|
| Ketone Supplement | Experimental | Ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" (Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.) 12g of ketones, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit. Receives: Dietary Supplement: ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,; Diagnostic Test: magnetic resonance imaging session |
| Placebo Beverage | Placebo comparator | Placebo beverage, visually matched, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit. Receives: Diagnostic Test: magnetic resonance imaging session; Dietary Supplement: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group changes in the total milligrams of benzodiazepines given to subjects during alcohol withdrawal management after receiving either ketone supplement or placebo beverage after 4 days of study intervention.
Patients in alcohol withdrawal management receive benzodiazepines measured in milligrams to treat their alcohol withdrawal symptoms. The primary outcome of this study is to compare the group differences in the amounts of benzodiazepines given to subjects after receiving either a ketone supplement or placebo beverage after 4 days, while undergoing in-patient acute withdrawal management.
Measured: 4 days
Secondary outcomes (2)
To measure the group differences of BHB levels in millimoles, in subjects receiving ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention.
Subjects will undergo a high-field strength, 7 Tesla 1H-MRS scan to measure brain BHB levels in millimoles after the 4 days of the study intervention.
Measured: 4 days
To measure the group differences of Gamma-Aminobutyric Acid levels in millimoles in subjects receiving a ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention.
Subjects will undergo a high-field strength, 7 Tesla 1H-MRS scan to measure brain Gamma-Aminobutyric Acid levels in millimoles after the 4 days of the study intervention.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-groups design clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Corinde Wiers, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559995
- Sponsor's protocol ID
- 856689
- Other IDs
- 5R21AA031337
- Acronym
- KSAW
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No