NCT05937893

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-14
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2023-07-10
• Last updated: 2024-12-11

Locations

1 site across 1 country: United States