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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
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.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,865 Previous Clinical Trials
2,742,725 Total Patients Enrolled
84 Trials studying Alcoholism
10,359 Patients Enrolled for Alcoholism
Chathura Kumaragamage, PhDPrincipal InvestigatorBioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging
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