Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder

Launched by UNIVERSITY OF PENNSYLVANIA · Aug 19, 2021

Keywords

ClinConnect Summary

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...

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Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria for both study groups (AUD and controls)
• • 1. Age 21 years to 65 years old.
• • 2. Willingness to provide signed, informed consent and commit to completing the procedures in the study
• • 3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
• • 4. Participants must agree to not consume alcohol beverages for 24 hours prior to each laboratory session.
• Inclusion criteria for the AUD group:
• • 5. Meets DSM-5 criteria for current AUD
• • 6. Participants report average weekly ethanol consumption of at least 15 standard drinks weekly over the past month prior to consent (self-report)
• • 7. Minimum 1 year history of heavy drinking (self-report).
• • 8. Must have had last drink within 1 week of PET visits.
• • 9. Alcohol specified as the preferred drug (self-report).
• Inclusion criteria for the control group:
• • 10. AUDIT score \< 6
• • 11. Drinks alcohol 15 standard drinks or less per month and 3 or less standard drinks per occasion.
• Exclusion both groups:
• • 1. Females who are pregnant or breast-feeding will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test prior to FDG injection.
• • 2. Unwilling or unable to refrain from use, within 24 hours of FDG PET/CT scan procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory drugs).
• • 3. Current DSM-5 diagnosis of a major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders that are mild/moderate in both groups; and alcohol in the AUD group) that required hospitalization, or that required daily medications for over 4 weeks in the past year (i.e., antidepressants; anticholinergics; antipsychotics; anxiolytics; lithium; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics).
• • 4. 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).
• • 5. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
• • 6. Currently suffering from or with a history of stroke and/or stroke related spasticity per medical record review or self report.
• • 7. History of seizures per medical record review or self report.
• • 8. HIV positive, as the human immunodeficiency virus may affect the brain, per medical record review or self report or by testing at screening.
• • 9. Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. (self-report, medical record review).
• • 10. 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.
• • 11. Significant claustrophobia or other medical condition preventing subject from lying comfortably flat on his/her back for up to 2 hours in the MRI or PET scanner (self-report).
• • 12. BMI \> 35, imaging data acquisition is impaired with high-weight individuals).
• • 13. Vision problems that cannot be corrected with glasses.
• • 14. Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.
• Exclusion criteria for the control group:
• • 15. Current DSM-5 diagnosis of Alcohol use disorder