Barnett Brian S, Vest M Frances, Delatte Marcus S, King Iv Franklin, Mauney Erin E, Coulson Anthony J, Nayak Sandeep M, Hendricks Peter S, Greer George R, Murnane Kevin S
Department of Psychiatry and Psychology, Neurological Institute, Cleveland Clinic, Lutheran Hospital, 1730 W 25th Street Floor 5E, Cleveland, OH, 44113, USA.
Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, EC-10 Cleveland Clinic, Cleveland, OH, 44195, USA.
Psychopharmacology (Berl). 2025 Jan;242(1):27-43. doi: 10.1007/s00213-024-06722-6. Epub 2024 Dec 4.
There is increasing interest in establishing psychedelic research programs at academic medical centers. However, psychedelics are intensely psychoactive, carry considerable sociopolitical baggage, and most are Schedule I drugs, creating significant potential impediments to implementation. There is little formal guidance for investigators on navigating the complex on-the-ground obstacles associated with establishing psychedelic research programs.
This article provides recommendations that may be helpful to investigators seeking to work with psychedelics, with a focus on academic medical centers in the United States.
The academic literature on relevant matters is reviewed, and the authors provide observations from their experiences either working for relevant regulatory agencies or conducting basic science studies, investigator-initiated trials, or industry sponsored trials with psychedelics.
Investigators planning to conduct psychedelic research should cultivate broad institutional support early. Challenges related to securing funding, obtaining approval for an Investigational New Drug application from the Food and Drug Administration, clinical grade drug sourcing, obtaining a Schedule I researcher registration from the Drug Enforcement Administration and an equivalent state license (if required), preparing spaces for treatment and study drug storage, managing controlled substance inventory, engaging the local community, and other issues should be anticipated.
Investigators should anticipate several implementation challenges when planning to work with psychedelics. However, these are likely surmountable with planning, persistence, and assistance from colleagues and other experts.
在学术医疗中心建立迷幻药研究项目的兴趣与日俱增。然而，迷幻药具有强烈的精神活性，带有相当多的社会政治包袱，并且大多数属于附表一药物，这给项目实施带来了重大潜在障碍。对于研究人员而言，在应对与建立迷幻药研究项目相关的复杂实际障碍方面，几乎没有正式的指导。
本文提供了一些建议，可能对寻求使用迷幻药开展研究的人员有所帮助，重点关注美国的学术医疗中心。
回顾了相关主题的学术文献，作者根据自己在相关监管机构工作的经历，或进行基础科学研究、研究者发起的试验或行业赞助的迷幻药试验的经验提供了观察结果。
计划开展迷幻药研究的研究人员应尽早争取广泛的机构支持。应预见到与获取资金、获得美国食品药品监督管理局的研究性新药申请批准、临床级药物采购、从美国缉毒局获得附表一研究人员注册以及同等的州许可证（如需要）、准备治疗和研究药物储存空间、管理管制物质库存、与当地社区互动以及其他问题相关的挑战。
研究人员在计划使用迷幻药开展工作时应预见到若干实施挑战。然而，通过规划、坚持以及同事和其他专家的协助，这些挑战可能是可以克服的。
