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

NCT ID: NCT05937893

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2024-05-15

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.

Detailed 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.

Conditions

BHB Transport; Alcohol Use Disorder

Keywords

BHB; AUD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Alcohol consumer (AC) participants

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

Group Type: OTHER

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

Intervention Type: 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.

Healthy participants

Healthy adult volunteers who are not dependent on alcohol.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chathura Kumaragamage, PhD

Role: PRINCIPAL_INVESTIGATOR

Bioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging

Locations

The Anlyan Center (TAC)

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000035050

Identifier Type: -

Identifier Source: org_study_id