Swieczkowski Damian, Kwaśny Aleksander, Ciurkowska Patrycja, Pruc Michal, Szarpak Lukasz, Cubała Wiesław Jerzy
Department of Toxicology, Faculty of Pharmacy, Medical University of Gdansk, Gdansk, Poland.
Department of Clinical Research and Development, LUXMED Group, Warsaw, Poland.
J Psychopharmacol. 2025 Sep;39(9):1014-1022. doi: 10.1177/02698811251353250. Epub 2025 Jul 11.
Although classic psychedelic trials show therapeutic potential, the limited diversity of participants raises concerns about generalizability and safety.
This study assesses the representation of race, ethnicity, and sex in interventional clinical trials of psilocybin and lysergic acid diethylamide (LSD) to evaluate disparities in participant diversity.
We conducted a cross-sectional analysis of interventional trials registered on ClinicalTrials.gov up to 12 January 2025 that focused on classic psychedelics (psilocybin, psilocin, LSD, DMT, 5-MeO-DMT, and mescaline). Eligible trials were phases 2-4 and targeted psychiatric disorders or symptoms. Trials involving only healthy participants were excluded. Two reviewers extracted trial-level data independently; discrepancies were resolved by consensus.
Nine eligible trials included eight with psilocybin and one with LSD. In the psilocybin trials ( = 501), the age of participants ranged from 34.3 to 56.3 years; 47.7% were women. White participants accounted for 87.2%, while Black participants accounted for 3.0%, and Asian individuals accounted for 5.0%. Ethnicity was reported in 4 of 8 psilocybin trials ( = 134), with 13.4% identifying as Hispanic or Latino. In four U.S.-only trials( = 139), participation-to-population ratios (PPRs) confirmed the underrepresentation of Black (PPR = 0.317) and Asian participants (PPR = 0.799). The LSD trial ( = 11) included older adults (average age: 51.7 years) who did not provide any information on race or origin.
The limited diversity in psychedelic trials demonstrates the need for broader recruitment. Without better representation, the safety and efficacy of these therapies remain uncertain. Standardized reporting and targeted strategies are essential to ensure equity.
尽管经典迷幻剂试验显示出治疗潜力，但参与者的有限多样性引发了对普遍性和安全性的担忧。
本研究评估了裸盖菇素和麦角酸二乙酰胺（LSD）介入性临床试验中种族、民族和性别的代表性，以评估参与者多样性方面的差异。
我们对截至2025年1月12日在ClinicalTrials.gov上注册的介入性试验进行了横断面分析，这些试验聚焦于经典迷幻剂（裸盖菇素、脱磷酸裸盖菇素、LSD、二甲基色胺、5-甲氧基二甲基色胺和三甲氧苯乙胺）。符合条件的试验为2-4期，针对精神疾病或症状。仅涉及健康参与者的试验被排除。两名评审员独立提取试验层面的数据；差异通过协商解决。
九项符合条件的试验中，八项涉及裸盖菇素，一项涉及LSD。在裸盖菇素试验（n = 501）中，参与者年龄在34.3至56.3岁之间；47.7%为女性。白人参与者占87.2%，黑人参与者占3.0%，亚洲人占5.0%。八项裸盖菇素试验中的四项（n = 134）报告了种族，其中13.4%的人认定为西班牙裔或拉丁裔。在仅在美国进行的四项试验（n = 139）中，参与率与人口比率（PPR）证实黑人（PPR = 0.317）和亚洲参与者（PPR = 0.799）的代表性不足。LSD试验（n = 11）纳入了老年人（平均年龄：51.7岁），他们未提供任何关于种族或出身的信息。
迷幻剂试验中有限的多样性表明需要更广泛地招募参与者。如果没有更好的代表性，这些疗法的安全性和有效性仍不确定。标准化报告和针对性策略对于确保公平性至关重要。
