Alcohol Use DisorderPhase 2/3NCT06173973
Effects of Ketone Supplementation on Acute Alcohol Withdrawal
A Phase 2/3 study testing Kenetik; Ketone Concentrate in people with Alcohol Use Disorder and Alcohol Withdrawal, run by University of Pennsylvania at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Withdrawal, Alcohol Dependence
- What is being tested?
- Kenetik; Ketone Concentrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2024to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets current DSM-5 criteria for AUD and admitted for alcohol withdrawal management treatment at Caron Treatment Center
- Willingness to provide signed, informed consent and commit to completing the procedures in the study
Who cannot join
- 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.
- Currently pregnant or lactating, based on urine pregnancy test and clinical exam.
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104
Caron Treatment Center
Wernersville, Pennsylvania, 19565
About this study
Official title: Effects of Ketone Supplementation on Acute Alcohol Withdrawal Symptoms During Alcohol Withdrawal Management
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.
Read the detailed description
This is a 5 day double-blinded, placebo-controlled intervention study of 50 treatment-seeking individuals with AUD, who are receiving detoxification treatment at Caron Treatment Center. Participants will be recruited for participation within 48 hours of admission to the inpatient unit. Participants will be consented and randomized to receive 10 g of ketone supplement three times daily (n=30; 1,3-butanediol and D-hydroxybutyric acid from Kenetik, VitaNav Inc., Washington D.C.) for 5 days or a placebo beverage (n=20). Benzodiazepines and other "comfort" medications will be administered daily following the Caron withdrawal management protocol, with additional benzodiazepines administered based on withdrawal symptoms, monitored with the revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar). The CIWA-Ar is given three or more times per day clinically to determine patient withdrawal levels and adjust medication dosages. Total daily maximum CIWA-Ar 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 and alcohol craving questions will assess differences between treatment groups.
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal, Alcohol Dependence, Ketosis
- Being tested
- Kenetik; Ketone Concentrate, Isocaloric dextrose placebo
- Keywords
- Alcohol Use Disorder, Alcohol Withdrawal, Alcohol Dependence, Ketone Supplement, Ketosis
- Medical subject headings
- Alcoholism, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kenetik; Ketone ConcentrateDietary supplement
Also called D-hydroxybutyric acid and R-1,3 butanediol
Ketone Supplement
Isocaloric dextrose placeboDietary supplement
Drink that is taste and visually matched to Ketone supplement
| Study group | Role | What they receive |
|---|---|---|
| Ketone Supplement | Active comparator | Ketone Supplement drink with 10 g ketones three times daily for five days. Receives: Dietary Supplement: Kenetik; Ketone Concentrate |
| Placebo Beverage | Placebo comparator | Matching Placebo drink three times daily for five days Receives: Dietary Supplement: Isocaloric dextrose placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg).
To examine the effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg), while undergoing inpatient acute withdrawal management.
Measured: 5 days
Secondary outcomes (1)
Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores (daily maximum scores).
To examine the effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores (daily maximum scores, range 0-67) while undergoing inpatient acute withdrawal management.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start11 Mar 2024
- Primary completionDec 2026 (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
- Placebo controlled, Double blinded study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corinde Wiers, PhD, University of Pennsylvania
- Investigators
- Corinde E Wiers, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173973
- Sponsor's protocol ID
- 854682
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No