NCT04831684已完成1 期
Effects of a Novel mGluR5 Negative Allosteric Modulator on Alcohol Drinking, Neurochemistry, and Brain Reactivity to Alcohol Cues in Alcohol Use Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Number of drinks consumed during bar-lab paradigm (free drinking period)
研究概览
简要总结
This study evaluates the effects of the medication GET73 among non-treatment-seeking individuals who regularly drink alcohol. Participants in the study will take GET73 or placebo for an 8-day study. There are 4 study visits including 2 MRI scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-40 (to focus on an age group still on a trajectory of increasing alcohol consumption, consistent with our pilot data and past iterations of the ARC).
- •Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder, with at least Moderate severity.
- •Reports drinking, on average, at least 20 standard alcoholic drinks per week for at least the past 3 months.
- •Currently not engaged in, and does not want treatment for, alcohol-related problems.
- •Able to read and understand questionnaires and informed consent.
- •Lives within 50 miles of the study site.
- •Able to maintain abstinence from alcohol the evening prior to appointments (without the aid of detoxification medications), as determined by self-report and breathalyzer measurements.
- •Amenable to drinking liquor in fruit juice.
排除标准
- •Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
- •Any psychoactive substance use (except marijuana and nicotine) within the last 30 days, as indicated by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels.
- •Current DSM-5 Axis I diagnosis, including major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.
- •Current suicidal ideation or homicidal ideation.
- •Using CYP2C19 and/or CYP3A4 inhibitors or inducers in the 14 days before dosing or during the study.
- •Need for maintenance or acute treatment with any psychoactive medication, including antiepileptic medications.
- •Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).
- •History of severe alcohol withdrawal (e.g., tremor, sweating, anxiety, seizure, delirium tremens), as evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
- •Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
- •Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.
- •Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening.
- •Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- •Current charges pending for a violent crime (not including DUI-related offenses).
- •Lack of a stable living situation.
- •Presence of ferrous metal in the body, as evidenced by metal screening and self-report.
- •Severe claustrophobia or extreme obesity that preclude placement in the MRI scanner.
- •Neurological disease or history of head injury with > 2 minutes of unconsciousness.
研究组 & 干预措施
Group A
Placebo Comparator
干预措施: Placebo (Drug)
Group B
Experimental
干预措施: GET73 (Drug)
结局指标
主要结局
Number of drinks consumed during bar-lab paradigm (free drinking period)
时间窗: 165 minutes
Change in Gamma aminobutyric acid (GABA) and glutamate levels
时间窗: baseline to day 7
Acquired via spectroscopy sequence completed at baseline and day 7 scans
Levels of cortical activation to visual cues of alcohol
时间窗: baseline to day 7
Acquired via functional magnetic resonance imaging completed at baseline and day 7 scans
次要结局
未报告次要终点
研究者
James Prisciandaro
Associate Professor
Medical University of South Carolina
研究点 (1)
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