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治疗酒精使用障碍的5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT):一个开放标签,第二阶段,概念验证,临床试验

John Marsden^1,2, Michael Kelleher^1,2, Fiona Dunbar³

¹Addictions Department, School of Academic Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Addiction (Abingdon, England)

|December 10, 2025

概括

这项研究表明,BPL-003,一种新型的5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT),是安全有效的治疗酒精使用障碍 (AUD). 当参与者与认知行为疗法 (CBT) 一起接受BPL-003治疗时,他们体验到酒精消耗和渴望减少.

科学领域:

心理药理学心理药理学
临床心理学临床心理学
成药物药物药物药物

背景情况:

酒精使用障碍 (AUD) 是一个重要的公共卫生问题.
迷幻化合物正在研究它们在治疗AUD中的治疗潜力.
BPL-003是一种新型的5-甲基-N,N-二甲基三胺 (5-MeO-DMT) 酸盐的鼻腔配方.

研究的目的:

评估BPL-003单次鼻入剂对中度至重度AUD患者的安全性和耐受性.
探索BPL-003在减少酒精消费和渴望方面的初步疗效.
评估BPL-003在10周的认知行为疗法 (CBT) 计划中使用时的效果.

主要方法:

进行了一项开放式的2a期单剂量临床试验,共有12名参与者.
参与者接受了10毫克BPL-003的鼻内注射,得到心理辅助的支持.
安全性通过体检,实验室测试和不良事件监测来评估;有效性通过12周的酒精使用,渴望和生活质量指标来衡量.

主要成果:

BPL-003证明了可接受的安全性和耐受性,所有治疗出现的不良事件 (TEAE) 都是轻度或中度的.
在12周后,参与者表现出禁酒日数显著增加 (33.2%至80.8%),大量饮酒日数减少 (56.2%至13.2%).
50%的参与者实现了持续的禁欲,幸福感和生活质量的整体指标得到了改善.

结论:

一次剂量BPL-003 (10毫克) 与CBT一起用于AUD治疗是安全的,并且耐受良好.
初步证据表明,BPL-003在减少酒精渴望和消费方面具有有效性.
这些发现需要在更大的,受控的临床试验中对AUD治疗进行进一步的研究.

关键词:

5-MeO-DMT 5-MeO-DMT是什么意思? 5-MeO-DMT是什么意思?在BPL-003中,我们可以使用BPL.酒精使用障碍饮酒障碍认知行为疗法是一种认知行为疗法.迷幻药物迷幻药物是一种精神药物.迷幻药辅助治疗是一种心理治疗.

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