search
Back to results

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

Primary Purpose

BHB Transport, Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for BHB Transport focused on measuring BHB, AUD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The Anlyan Center (TAC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Alcohol consumer (AC) participants

Healthy participants

Arm Description

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

Healthy adult volunteers who are not dependent on alcohol.

Outcomes

Primary Outcome Measures

Change in BHB levels in the brain
β-hydroxybutyrate blood levels in the brain will be assessed via MRSI.

Secondary Outcome Measures

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.

Full Information

First Posted
June 30, 2023
Last Updated
October 16, 2023
Sponsor
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT05937893
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BHB Transport, Alcohol Use Disorder
Keywords
BHB, AUD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol consumer (AC) participants
Arm Type
Other
Arm Description
Adult volunteers who are alcohol consumers drawn from both an outpatient population and recruited heavy drinkers from the community.
Arm Title
Healthy participants
Arm Type
Other
Arm Description
Healthy adult volunteers who are not dependent on alcohol.
Intervention Type
Other
Intervention Name(s)
Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BHB levels in the brain
Description
β-hydroxybutyrate blood levels in the brain will be assessed via MRSI.
Time Frame
Approximately 90 minutes after Baseline Assessment
Secondary Outcome Measure Information:
Title
Change in GABA levels in the brain
Description
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.
Time Frame
Approximately 90 minutes after Baseline Assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chathura Kumaragamage, PhD
Phone
(203) 785-5296
Email
chathura.kumaragamage@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robin de Graaf, PhD
Phone
(203) 785-6203
Email
robin.degraaf@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chathura Kumaragamage, PhD
Organizational Affiliation
Bioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Anlyan Center (TAC)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data from this study be submitted to the NIMH data archive (NDA) at the NIH.
IPD Sharing Time Frame
Following study completion and final funder reporting obligations.
IPD Sharing URL
https://nda.nih.gov/

Learn more about this trial

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

We'll reach out to this number within 24 hrs