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

NCT05937893 | Completed

• 2 other identifiers: 2000035050000
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain.

Conditions

BHB Transport; Alcohol Use Disorder

Keywords

BHB; AUD

Outcome Measures

Primary Outcomes (1)

• Change in BHB levels in the brain

  β-hydroxybutyrate blood levels in the brain will be assessed via MRSI.

  Approximately 90 minutes after Baseline Assessment

Secondary Outcomes (1)

• Change in GABA levels in the brain

  Approximately 90 minutes after Baseline Assessment

Study Arms (2)

Alcohol consumer (AC) participants

OTHER

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

Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans

Healthy participants

OTHER

Healthy adult volunteers who are not dependent on alcohol.

Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans

Interventions

Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans OTHER

Following baseline scans, the participant will orally consume the keto-ester, for subsequent scans which will include repeated BHB MRSI acquisitions to dynamically measure BHB labeling in the brain, followed by a final GABA MRSI acquisition.

Alcohol consumer (AC) participants; Healthy participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For AUD patients: individuals assessed to be with mild to - medium severity according to the DSM-5 criteria.
• For non-dependent heavy at-risk drinkers: must be Individuals who consume more than 14 drinks per week for men or more than 8 drinks per week for women, for at least the last 2 months.
• For healthy controls: must be light drinkers not dependent on alcohol, who consume fewer than 2 drinks per week for at least the last 6 months.
• English speaking
• Can read and understand a study the consent form

You may not qualify if:

• Non-English speaking
• Unable to read and understand the consent form
• History of alcohol withdrawal in the last 12 months. This will reduce chances of a volunteer having withdrawal symptoms in the middle of the experiment.
• Participants with a history of psychiatric conditions (that include PTSD, schizophrenia, and bipolar disorders), or a history of neurological conditions
• Women who test positive on a pregnancy test collected on either the screening visit or day of the study.
• Healthy subjects identified with substance use with the exception of tobacco and alcohol will be excluded.
• AC subjects identified with substance use, with the exception of tobacco, alcohol, and mild cannabis use disorder (based on the DSM-5 criteria during the medical history) in the last 6 months, will be excluded.
• Persons unable to refrain from alcohol use for 48 hours and undergo a 10-hour fast prior to the study

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

The Anlyan Center (TAC)

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Chathura Kumaragamage, PhD

  Bioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: August 14, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Following study completion and final funder reporting obligations.

Locations

US (1)