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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937893
• Other study ID #: 2000035050
• Secondary ID: 000
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Chathura Kumaragamage, PhD
• Phone: (203) 785-5296
• Email: chathura.kumaragamage[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary 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. Furthermore, BHB levels in identified brain regions will be compared against measures of craving.

The secondary objective of this study is to investigate if GABA levels will be elevated in key brain regions relative to the baseline scan in AC subjects due to preferential BHB metabolism. The goal is to acquire preliminary data to apply for an R01 or equivalent grant submission to pursue this metabolic therapy in greater detail using the state-of-the-art MRSI platform at Yale University to study alcohol use disorders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	The Anlyan Center (TAC)	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BHB levels in the brain	ß-hydroxybutyrate blood levels in the brain will be assessed via MRSI.	Approximately 90 minutes after Baseline Assessment
Secondary	Change in GABA levels in the brain	GABA levels will be assessed in the brain via MRSI to determine if they are elevated in key brain regions relative to the baseline scan.	Approximately 90 minutes after Baseline Assessment