ALCOHOL CUE HUMAN LABORATORY STUDY TESTING ASP 8062

酒精提示人体实验室研究测试 ASP 8062

• 批准号: 10953468
• 负责人: LARA RAY
• 金额: $ 28.25万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2023-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10953468
• 关键词: ALCOHOL; CUE; HUMAN; LABORATORY; STUDY

The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

本研究的主要目的是评价ASP 8062（25 mg，每日一次）和匹配安慰剂在人类实验室范例中对中度至重度酒精使用障碍（AUD）受试者（经精神疾病诊断和统计手册-第五版（DSM-5™）证实）每日给药2周后酒精线索诱发的酒精渴求的影响。次要目的包括评价ASP 8062（25 mg，每日一次）和匹配安慰剂在研究治疗期最后4周内对减少饮酒、酒精渴求、吸烟（吸烟者）和尼古丁使用（尼古丁使用者）、情绪、睡眠、酒精使用不良后果、研究保留以及安全性和耐受性的影响。