Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder (NCT05015881) | Clinical Trial Compass
By InvitationPhase 2/3
Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder
United States20 participantsStarted 2021-11-01
Plain-language summary
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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 21 years to 65 years old.
✓. Willingness to provide signed, informed consent and commit to completing the procedures in the study
✓. 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.
✓. Participants must agree to not consume alcohol beverages for 24 hours prior to each laboratory session.
✓. Meets DSM-5 criteria for current AUD
✓. Participants report average weekly ethanol consumption of at least 15 standard drinks weekly over the past month prior to consent (self-report)
✓. Minimum 1 year history of heavy drinking (self-report).
✓. Must have had last drink within 1 week of PET visits.
Exclusion criteria
✕. 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.
✕. 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).
✕. 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).
✕. 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).
✕. 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.
✕. Currently suffering from or with a history of stroke and/or stroke related spasticity per medical record review or self report.
✕. History of seizures per medical record review or self report.
✕. HIV positive, as the human immunodeficiency virus may affect the brain, per medical record review or self report or by testing at screening.