Khaleel Rajwani

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.

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.

The current revival of interest in classic psychedelics and other psychoactives such as ketamine and MDMA, coupled with changes to their regulatory status in many jurisdictions, necessitates rigorous ethical guidelines both within and beyond clinical and scientific contexts. This paper examines crucial ethical, philosophical, and policy considerations needed to ensure psychedelic use across various settings remains equitable, beneficial, consensual, and safe, with appropriate accountability mechanisms for addressing potential harms. We seek to broaden the lens beyond the medical model of psychedelics to include potentially valuable non-medical applications that could benefit individuals, communities, and society. With popular interest in psychedelics growing outside of therapeutic and research settings, there is a need to determine which aspects of any proffered guidelines, or underlying principles, should be applied similarly across contexts and in what ways there should be flexibility and/or context-sensitivity in their interpretation or application. In developing such guidelines, we suggest the “treatment versus enhancement” distinction – and associated debates familiar from bioethics and philosophy of medicine – requires renewed attention. We argue that neglecting non-medical and broad scientific use cases for psychedelics may have important implications for a range of ethical issues surrounding psychedelic use and research, including concerns about psychedelic hype and exceptionalism (both positive and negative), therapeutic touch, informed consent, data-gathering, and balancing access and safety. We conclude with suggestions for future directions in research and policy in the burgeoning area of psychedelic bioethics, stressing the importance of incorporating the perspectives of a diversity of stakeholders and fostering cross-sector collaboration.

Après des cas très médiatisés d’agressions sexuelles et d’autres comportements contraires à l’éthique de la part de thérapeutes, la recherche clinique récente sur les drogues psychédéliques a généralement rendu obligatoire l’enregistrement vidéo de toutes les séances de thérapie. Dans cet article, j’examine les questions éthiques liées à l’enregistrement vidéo dans le contexte unique des séances de thérapie psychédélique. Je commence par résumer les avantages et les risques importants liés à l’enregistrement vidéo, puis ensuite les préoccupations éthiques concernant l’enregistrement obligatoire des séances de thérapie psychédélique du point de vue du patient, et je soutiens que ces préoccupations doivent être prises au sérieux par les cliniciens et chercheurs. J’examine également le point de vue selon lequel l’enregistrement vidéo est essentiel pour la sécurité des cliniciens. Acceptant la légitimité des préoccupations des deux points de vue, j’expose quelques considérations de base sur le consentement éclairé qui pourraient générer un dialogue autour des préoccupations potentielles des patients. Je défends l’option de refuser, tant pour les patients que pour les cliniciens. En conclusion, je souligne l’importance de poursuivre l’enquête bioéthique critique et la recherche qualitative concernant les pratiques d’enregistrement vidéo dans le contexte des thérapies assistées par les psychédéliques.

Recent evidence shows significant potential for therapies involving psychedelic substances such as psilocybin and MDMA to improve clinical outcomes for patients experiencing various mental disorders. However, research to date focuses almost exclusively on adults. I argue that adolescents should be included in research into psychedelic therapies. First, I demonstrate the pressing need for novel interventions to address the growing mental health burden of adolescents, and I draw on empirical evidence to show that research into psychedelic therapies presents an opportunity to address this shortfall. Secondly, I argue that psychedelics pose low risk to young patients, particularly relative to existing psychiatric medications. I then address two major concerns specific to adolescent contexts. First, I address the risks of using psychedelic substances at earlier stages of physiological and cognitive development. I note that the lack of understanding of the risks underscores the need for including adolescents in research. I then address the added complexity of consent in the adolescent context. I highlight some additional concerns that should be addressed in an “enhanced” informed consent process for adolescents and defend the view that capable adolescents should be able to consent to psychedelic interventions. I ultimately hold that including adolescents in emerging psychedelic research has the potential to substantiate innovative treatments that could improve their clinical outcomes, long-term mental health and quality of life.