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Keto-ester for Alcoholism

N/A

Recruiting

Led By Chathura Kumaragamage, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 90 minutes after baseline assessment

Awards & highlights

Study Summary

This trial looks at how alcohol affects brain chemistry and if it can increase levels of a chemical called BHB.

Who is the study for?

This trial is for adults with mild to medium alcohol use disorder, non-dependent heavy drinkers, and light-drinking healthy controls. Participants must speak English and understand the consent form. Exclusions include recent alcohol withdrawal, psychiatric or neurological conditions, pregnancy in women, substance use (except tobacco/alcohol/mild cannabis for AUD), and inability to abstain from alcohol or fast before the study.Check my eligibility

What is being tested?

The study tests if a keto-ester can increase beta-hydroxybutyrate (BHB) levels in the brain of those with Alcohol Use Disorder (AUD). It involves consuming a keto-ester followed by brain scans using Magnetic Resonance Spectroscopic Imaging to observe changes.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort at the site of consumption or during imaging procedures. Keto-esters might cause gastrointestinal issues like nausea or stomach upset.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 90 minutes after baseline assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 90 minutes after baseline assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 90 minutes after baseline assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in BHB levels in the brain

Secondary outcome measures

Change in GABA levels in the brain

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy participantsExperimental Treatment1 Intervention

Healthy adult volunteers who are not dependent on alcohol.

Group II: Alcohol consumer (AC) participantsExperimental Treatment1 Intervention

Adult volunteers who are alcohol consumers drawn from both an outpatient population and recruited heavy drinkers from the community.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,541 Total Patients Enrolled

84 Trials studying Alcoholism

10,359 Patients Enrolled for Alcoholism

Chathura Kumaragamage, PhDPrincipal InvestigatorBioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging

Frequently Asked Questions

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

Are there still vacancies available for the trial participants?

"Based on the information available to us through clinicaltrials.gov, this trial is actively searching for individuals who fit its criteria. This experiment was first posted on August 14th 2023 and subsequently updated October 16th of the same year."

Answered by AI

What is the aggregate size of the population being studied in this clinical experiment?

"Affirmative. Clinicaltrials.gov indicates that this investigation, which was first shared on August 14th 2023, is still recruiting participants. The team behind the study needs to find around 20 volunteers at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)

2023. "Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05937893.