Relationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Dietary Supplement, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: Accepts Healthy Volunteers
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• 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.

• Alcohol specified as the preferred drug (self-report).

• AUDIT score < 6

• Drinks alcohol 15 standard drinks or less per month and 3 or less standard drinks per occasion.

• Exclusion both groups:

• 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.

• 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).

• 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.

• 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).

• BMI > 35, imaging data acquisition is impaired with high-weight individuals).

• Vision problems that cannot be corrected with glasses.

• Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.

Locations
United States
Pennsylvania
University of Pennsylvania Center for Studies of Addiction
Recruiting
Philadelphia
Contact Information
Primary
Timothy Pond, MPH
timpond@pennmedicine.upenn.edu
215-746-1959
Backup
Juliana Byanyima, BS
Juliana.Byanyima@Pennmedicine.upenn.edu
215-746-7726
Time Frame
Start Date: November 1, 2021
Estimated Completion Date: December 2025
Participants
Target number of participants: 20
Treatments
Active Comparator: Ketone ester + echocardiogram + PET FDG scanning visit.
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.
Other: Echocardiogram + PET FDG scanning visit.
Subjects will complete a echocardiogram + PET scanning visit. 2-Deoxy-2-[18F] fluoro-D-glucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scan.
Authors
Reagan Wetherill, Jacob Dubroff, Paco Bravo, Henry R. Kranzler, Robert Doot, Corinde E Wiers
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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