Ketone supplement to reduce alcohol withdrawal symptoms and change brain metabolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled 4-day intervention enrolling 30 adults admitted for alcohol detoxification at the Hospital of the University of Pennsylvania Cedar Detox Center. Participants are randomized within 24 hours of admission to receive either 12 g ketone supplement three times daily (n=15) or a placebo beverage (n=15) while receiving standard benzodiazepine and comfort medication management guided by CIWA scores. Daily outcomes include CIWA scores, benzodiazepine dosing, mood and craving measures, analyzed with repeated measures to compare treatment groups over time. After the 4-day intervention all participants complete an approximately 1.5-hour magnetic resonance imaging session to examine effects on brain metabolism.

Why it matters

Who can join: the full rules

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.

Where it's running

• Center for Studies of Addiction
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Corinde Wiers, Ph.D. — University of Pennsylvania
• Study coordinator: Timothy Pond, MPH
• Email: timpond@pennmedicine.upenn.edu
• Phone: 215-746-1959

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.