Should People With a History of Psychosis Be Included in Psychedelic Research?

Abstract

The exclusion of all patients with a personal or family history of psychosis from psychedelic therapy research is a significant ethical concern. Beginning with a summary of the historical entanglement and disentanglement of psychedelic and psychosis research in Western psychiatry, I then discuss some of the important clinical and socio-cultural reasons why having a personal or family history of psychosis has become a standardized exclusion criterion in almost all contemporary research involving psychedelic drugs. While acknowledging that a high degree of caution is warranted, I contend that the exclusion of patients with a history of psychosis results in significant harms related to safety, accessibility, autonomy, and equity. Drawing on the paradigmatic case of the broad exclusion of pregnant people from drug research, I argue that, rather than preventing harmful consequences, a protectionist and exclusionary approach redistributes these harms in ethically problematic ways. People with a history of psychosis deserve equitable access to the benefits of psychedelic therapy research. Generating more robust safety data, dosage recommendations, and therapeutic guidelines for this group will improve clinical practice and reduce psychedelic-related harm broadly. I also explore the growing scientific literature that suggests novel psychedelic therapies could play a role in the treatment of psychosis, particularly in the case of negative symptoms of schizophrenia for which effective treatments are urgently needed. Ultimately, I critique the dominant practice of psychosis-related exclusion and defend the view that cautious clinical psychedelic research involving individuals with personal or family history of psychosis is ethically imperative. Adopting a more inclusive approach to psychedelic research would ultimately improve safety, increase access, reduce inequities, and prevent long-term harms caused by blanket exclusion.