Ketone Ester for Alcoholism

Overseen By Juliana Byanyima, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Pennsylvania

Must not be taking: Antidepressants, Antipsychotics, Anxiolytics, others

Disqualifiers: Pregnancy, Major psychiatric disorder, Stroke, Seizures, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn more about how a nutritional supplement "ketone ester" (deltaG ®) has an effect on brain and heart function and on alcohol consumption in individuals with and without alcohol use disorder. The study will use Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scans after a single dose of ketone ester or Placebo in 10 people with alcohol use disorder and 10 healthy control volunteers.

Research Team

Corinde E Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults aged 21-65, with or without alcohol use disorder, who can commit to the study and avoid alcohol for 24 hours before sessions. Excluded are those with seizures, high BMI (>35), metal implants incompatible with MRI/PET scans, vision issues not corrected by glasses, serious medical/psychological conditions, HIV positive individuals, pregnant/breastfeeding women, and certain psychiatric diagnoses.

Inclusion Criteria

Alcohol specified as the preferred drug (self-report) (for AUD group)

Participants must agree to not consume alcohol beverages for 24 hours prior to each laboratory session

AUDIT score < 6 (for control group)

Exclusion Criteria

Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI (self-report checklist) or PET scanner

Positive urine drug screen positive for any substances, other than marijuana, on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary)

I've had a severe head injury with loss of consciousness, skull fracture, or bleeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person or virtual)

MRI Scan

Participants undergo an MRI scan to assess brain anatomy and function

1 hour

1 visit (in-person)

PET/CT Scan with Ketone Ester

Participants receive a ketone ester drink and undergo a PET/CT scan to assess brain and heart function

3-4 hours

1 visit (in-person)

PET/CT Scan without Ketone Ester

Participants undergo a PET/CT scan without the ketone ester to assess baseline brain and heart function

3-4 hours

1 visit (in-person)

Follow-up

Participants are monitored for any side effects and changes in health after the study visits

1 day

1 follow-up call

Treatment Details

Interventions

• FDG
• Ketone Ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate)

Trial Overview The study tests how a nutritional supplement 'ketone ester' affects brain and heart function and alcohol consumption in people with alcohol use disorder compared to healthy volunteers. It involves taking a single dose of ketone ester or placebo followed by PET/CT scans using FDG.

Participant Groups

Group I: Echocardiogram + PET FDG scanning visit. Experimental Treatment 1 Intervention

Subjects will complete a echocardiogram + PET scanning visit. 2-Deoxy-2-\[18F\] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.

Group II: Ketone ester + echocardiogram + PET FDG scanning visit. Active Control 2 Interventions

Subjects will drink single dose of ketone ester 1.9 kcal/kg + echocardiogram + PET scanning visit. Dietary Supplement: Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (R)-3-hydroxybutyrate (commercially available as DeltaG, (TdeltaS, Orlando, FL). 2-Deoxy-2-\[18F\] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+