Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder

The purpose of this research is to study how a nutritional ketone ester may affect brain and heart function in individuals who consume alcohol on a regular basis, and in healthy controls.

The study will see how the brain and heart responds, once after drinking the ketone ester and once without drinking the ester (baseline) using a test called an FDG PET/CT scan. PET/CT scans use small amounts of a radioactive imaging drug, a special camera and a computer to evaluate organ and tissue functions. FDG PET/CT scans are routinely done for evaluation of heart diseases. The study will test how the brain and heart function at rest and while viewing pictures of alcohol.

The study involves 4 or more visits: (1) a consent/screening visit, which can be completed in a single day or divided over multiple days. Portions of the screening may occur using telephone or video conference. (2) In-person MRI (if one hasn't been completed in the past year). (3) In-person study visit that includes the drinking of the ketone ester, a FDG PET/CT scan, and (4) a second in-person visit that a FDG PET/CT scan without drinking the ketone ester. Depending on the scheduling for each of these visits, study involvement will last approximately 8 weeks depending on scheduling restrictions. Following completion of the scan visits (next business day), study staff will follow-up with individuals by phone to ask about any changes to your health and to ensure that they did not experience any side effects from the ketone ester, MRI scan or FDG PET/CT scan.

Screening visit:

• Informed consent will happen before any study related procedures are performed. Staff will answer all questions during the process. The following will occur at the screening session:
• Demographic information, such as date of birth, age, biological sex, race, and ethnicity will be collected.
• Current address and contact information in order to register people into the University of Pennsylvania electronic medical record system.
• Collection of a urine sample of about 30 mL (approximately 2 tablespoons) to be used for urinalysis, drug screening and pregnancy in women.
• Breathalyzer test to measure breath alcohol concentration (BrAC). A 0.000% BrAC is required to continue with the visit.
• Vitals (blood pressure and pulse), weight and height. A doctor or nurse practitioner will do a brief physical exam.
• Brief psychiatric assessments called the 'CSSRS'. During these interviews, questions will be asked about current and past depressed mood symptoms, as well as other psychiatric symptoms, including suicidal thinking.
• Complete a brief mental ability test called the 'Shipley Institute of Living Scale'.
• Short interview regarding alcohol and smoking history, behaviors, and mood and any drug or alcohol use, and questions about any substance cravings or withdrawal symptoms.
• Psychological questionnaires related to substance use, cravings, risk behaviors, mental health, personality, depression and anxiety, quality of sleep.
• Complete questions about any current medication, recreational drugs or supplements use.
• Complete a questionnaire about the presence of metal in the body to determine if it is safe to undergo an MRI.
• A small amount of blood (approximately 2.75 tablespoons) will be drawn for screening lab tests (a blood count and chemistry panel), genetics and metabolite analysis.
• Complete an oral swab rapid HIV test. If the test is positive, study staff will draw a tablespoon of blood to conduct a confirmatory HIV blood test (i.e., to confirm the positive oral test). If the blood test are positive for HIV, we will provide a referral for medical care and a copy of the test results.
• Complete several computer-based tasks on a laptop that will be provided by the study team. These tasks will test the following brain cognition measures including: visual memory, willingness to delay a reward offered, response time in reacting to specific information on the screen, verbal learning and memory, impulsiveness, and reaction time and accuracy when asked to match up a series of test pictures that are different shapes and colors.