Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder

Launched by UNIVERSITY OF PENNSYLVANIA · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a ketone supplement can help manage alcohol withdrawal symptoms in adults with moderate to severe alcohol use disorder (AUD). Participants will receive either the ketone supplement or a placebo (a non-active treatment) during a four-day treatment period at the Hospital of the University of Pennsylvania. The goal is to see if the ketone supplement can improve brain function and ease withdrawal symptoms during this critical time.

To be eligible for this study, individuals should be between 18 and 65 years old, able to speak and understand English, and have a history of heavy drinking for at least three years. They must also be experiencing alcohol withdrawal symptoms and seeking treatment for their AUD. However, those with certain major health issues, severe psychiatric disorders, or specific medical conditions that could affect their participation will not be eligible. Participants can expect to receive close monitoring and support throughout the trial to ensure their safety and well-being.

Gender

ALL

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.