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

Yale University

Status: Completed

Conditions: BHB Transport; Alcohol Use Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05937893

2000035050

000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Alcohol consumer (AC) participants

Other group

Description:

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

Treatment:

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

Healthy participants

Other group

Description:

Healthy adult volunteers who are not dependent on alcohol.

Treatment:

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