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在建立迷幻研究计划的实际考虑.
Brian S Barnett1,2, M Frances Vest3, Marcus S Delatte4
1Department of Psychiatry and Psychology, Neurological Institute, Cleveland Clinic, Lutheran Hospital, 1730 W 25th Street Floor 5E, Cleveland, OH, 44113, USA.
Psychopharmacology
|December 3, 2024
概括
在学术中心建立迷幻研究计划需要克服重大监管和后勤障碍. 早期规划和机构支持对于克服心理药物开发中的这些挑战至关重要.
科学领域:
- 神经科学和药理学 神经科学和药理学
- 精神病学和临床心理学
- 监管科学 监管科学
背景情况:
- 在学术医疗中心对迷幻研究的兴趣越来越大.
- 迷幻药物由于精神活动,社会政治因素和附表I状态而带来了独特的挑战.
- 缺乏正式指导调查人员建立迷幻研究计划的调查人员.
研究的目的:
- 为与迷幻药物工作的调查人员提供建议.
- 专注于在美国学术医疗中心建立迷幻研究.
- 为克服实施障碍提供实际指导.
主要方法:
- 关于相关主题的学术文献的审查.
- 纳入来自监管机构和各种研究环境的作者经验 (基础科学,研究者发起的试验,行业赞助的试验).
主要成果:
- 培养广泛的机构支持对于迷幻研究至关重要.
- 预测融资,FDA新药研究 (IND) 批准和临床级别迷幻药的采购方面的挑战.
- 确保药物执法局 (DEA) 附表I研究员注册和国家许可证;为治疗和药物存储准备设施;管理受控物质库存;并与当地社区合作.
结论:
- 实施迷幻研究面临着几个预期的挑战.
- 这些挑战是可以通过彻底的规划,坚持和专家合作来克服的.
- 通过战略预见,成功建立迷幻研究计划是可行的.
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