Treatment for Alcohol Drinking

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Pennsylvania Center for Studies of Addiction, Philadelphia, PA
Alcohol Drinking+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a nutritional supplement can improve brain and heart function in people with alcohol use disorder.

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Eligible Conditions

  • Alcohol Drinking
  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 3 secondary outcomes in patients with Alcohol Drinking. Measurement will happen over the course of 4 hours.

4 hours
Amount of BHB (beta-hydroxybutyrate) (mmol/L)
Amount of FDG uptake (CMRg)
Amount of blood glucose (mmol/L or mg/dl)
FDG uptake (CMRg) in the brain and heart

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Ketone ester + echocardiogram + PET FDG scanning visit.
1 of 1
Active Control

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 hours for reporting.

Closest Location

University of Pennsylvania Center for Studies of Addiction - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Inclusion criteria for both study groups (AUD and controls)
Participants must agree to not consume alcohol beverages for 24 hours prior to each laboratory session.
Meets DSM-5 criteria for current AUD
You have consumed an average of 15 standard drinks per week over the past month. show original
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).
You are between the ages of 21 and 65 years old. show original
You are willing to provide signed, informed consent and commit to completing the procedures in the study. show original
You are 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. show original

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Alcohol Drinking by sharing your contact details with the study coordinator.