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ALCOHOL CUE HUMAN LABORATORY STUDY TESTING ASP 8062

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
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-09-17 至 2023-09-16

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项目成果

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中文摘要
翻译
本研究的主要目的是评估ASP8062, 25毫克,每天一次和匹配的安慰剂,在人类实验室范式中,每天给药2周后,在中度至重度酒精使用障碍(AUD)的受试者中,经精神障碍诊断与统计手册-第五版(DSM-5™)证实,对酒精提示引起的酒精渴望的影响。次要目标包括评估ASP8062, 25毫克,每天一次,并匹配安慰剂在减少饮酒量,酒精渴望,吸烟(吸烟者)和尼古丁使用(尼古丁使用者),情绪,睡眠,酒精使用的负面后果,研究保留,以及在研究治疗阶段的最后4周的安全性和耐受性方面的效果。
英文摘要
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.
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NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder
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