在全球临床试验数据库中注册的可卡因使用障碍正在进行的临床试验的特点
Journal of addiction medicine
|September 8, 2025
概括
大多数可卡因使用障碍 (CUD) 的临床试验不符合FDA的指导方针. 改善试验设计和协作是开发有效CUD治疗的关键.
科学领域:
- 成 药物 药物 药物 药物
- 临床试验设计 临床试验设计
- 监管科学 监管科学
背景情况:
- 可卡因使用障碍 (CUD) 影响140万美国人,没有FDA批准的治疗方法.
- 美国食品和药物管理局于2023年发布了兴奋剂使用障碍治疗试验指南草案.
- 这项研究回顾了当前的CUD试验与FDA建议的对比.
研究的目的:
- 系统地审查CUD正在进行的临床试验.
- 评估这些试验与FDA关于兴奋剂使用障碍的指导方针草案的一致性.
- 确定改善CUD治疗研究的差距和机会.
主要方法:
- 对6个国际临床试验数据库进行系统搜索.
- 包括药理学,行为,基于设备和混合CUD治疗的试验.
- 根据FDA的5个关键建议对试验的评估 (持续时间,结果措施,随机化,安慰剂,失明).
主要成果:
- 确定了38项CUD试验,主要来自美国 (32).
- 虽然大多数试验是随机的 (94.7%),但只有18.4%符合FDA的所有5个标准.
- 新的治疗方法如psilocybin和数字平台正在出现,但试验设计需要改进.
结论:
- 有希望的新的CUD治疗方法正在研究中.
- 许多目前的试验不符合FDA的设计建议.
- 加强监管遵守和研究人员与监管机构的合作对于推进CUD治疗至关重要.
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