NCT06559995 Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
| NCT ID | NCT06559995 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Pennsylvania |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-08-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Corinde Wiers, Ph.D.
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06559995 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06559995 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06559995 currently recruiting?
Yes, NCT06559995 is actively recruiting participants. Contact the research team at timpond@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06559995 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06559995 clinical trial?
NCT06559995 is sponsored by University of Pennsylvania. The principal investigator is Corinde Wiers, Ph.D. at University of Pennsylvania. The trial plans to enroll 30 participants.