Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in BHB levels in the brain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in BHB levels in the brain
时间窗: Approximately 90 minutes after Baseline Assessment
β-hydroxybutyrate blood levels in the brain will be assessed via MRSI.
次要结局
- Change in GABA levels in the brain(Approximately 90 minutes after Baseline Assessment)