Clinical trial NCT05937893: Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BHB Transport
Alcohol Use Disorder
Keywords: BHB
AUD
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in BHB levels in the brain
timeFrame: Approximately 90 minutes after Baseline Assessment
Secondary outcomes:
measure: Change in GABA levels in the brain
timeFrame: Approximately 90 minutes after Baseline Assessment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The Anlyan Center (TAC)
state: Connecticut
Study officials:
affiliation: Bioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging
name: Chathura Kumaragamage, PhD
role: PRINCIPAL_INVESTIGATOR
References: