David Yaden

Psychedelics are increasingly being studied and used in clinical and therapeutic contexts, prompting renewed ethical and regulatory debate. Claims of psychedelic exceptionalism—whether “negative,” portraying psychedelics as uniquely risky and thus requiring stricter oversight, or “positive,” portraying them as uniquely beneficial and thus exempt from ordinary ethical rules—have become common. In a recent article, we argued that while psychedelics may involve distinctive constellations of features, these do not justify fundamentally new ethical standards. In response, Daniel Villiger and, separately, Edward Jacobs, agreed that psychedelics should not be exempt from existing ethical standards (what Villiger calls Type A ethical exceptionalism) but suggested that their distinctive qualities may still warrant unique applications of those standards (Type B ethical exceptionalism). For example, Villiger argues that psychedelics possess certain features that do not, in his view, exist anywhere else in medicine, including the unpredictability and emotional intensity of the psychedelic experience, alongside a temporary lowering of psychological defences, leading to heightened suggestibility and sensitivity to context. He argues that such allegedly unique features call for exceptional policies around how existing ethical standards are to be applied—Type B exceptionalism. In this essay, we argue that the features Villiger identifies are only ethically significant insofar as they raise concerns about (inter alia) autonomy and vulnerability. But these concerns arise also in other medical settings. As such, policies addressing these issues would apply more broadly to other medical interventions raising similar concerns. Villiger thus fails to establish a genuine case for psychedelic ethical exceptionalism, even of the more modest, Type B variety.

Randomized controlled trials (RCTs) are considered the gold standard for demonstrating the efficacy of a treatment or intervention; however, the RCT study design alone is insufficient to prevent all forms of bias. In this paper, we review conflicts of interest and other biases that pose challenges to the methodological rigor of psychedelic RCTs, and explore recommended bias mitigation measures. We focus on biases of special relevance to psychedelic RCTs and methods of mitigating bias that we believe are actionable and urgent practices to implement in psychedelic research: (1) independent data assessment, (2) multisite trials, (3) quantitative bias analysis, and (4) open science practices. Although we advocate for the adoption of these practices in psychedelic research, they are not psychedelic specific. We suggest that the challenges posed by psychedelic research offer an opportunity for researchers to creatively find and implement solutions across the study lifecycle to reduce bias in other fields of clinical research.

When used clinically, psychedelics may appear unusual or even unique when compared to more familiar or long-standing medical interventions, prompting some to suggest that the ethical issues raised may likewise be exceptional. If that is correct, then perhaps psychedelics should be treated differently from other medical substances: for example, by being subjected to different ethical or evidentiary standards. Alternatively, it may be that psychedelics have more in common with various existing medical interventions than first meets the eye. We argue in favor of the latter position, drawing on parallels from earlier debates around genetic exceptionalism in bioethics. We suggest there are risks to adopting a stance of “psychedelic ethical exceptionalism,” and propose that consistent ethical rules and evidentiary standards should be applied across all relevant areas of clinical medicine. Importantly, this does not preclude the possibility that changes to existing standards should be made; but if so, this should not be justified by appealing to the alleged uniqueness of psychedelics.

ABSTRACT:Psychedelics, including psilocybin, and other consciousness-altering compounds such as 3,4-methylenedioxymethamphetamine (MDMA), currently are being scientifically investigated for their potential therapeutic uses, with a primary focus on measurable outcomes: for example, alleviation of symptoms or increases in self-reported well-being. Accordingly, much recent discussion about the possible value of these substances has turned on estimates of the magnitude and duration of persisting positive effects in comparison to harms. However, many have described the value of a psychedelic experience with little or no reference to such therapeutic benefits, instead seeming to find the experience valuable in its own right. How can we make sense of such testimony? Could a psychedelic experience be valuable even if there were no persisting beneficial effects? If so, how? Using the concept of psychological richness, combined with insights from the philosophy of aesthetics and the enhancement literature, this essay explores potential sources of value in the acute subjective experience, apart from the value derived from persisting beneficial effects.

Psychedelics such as psilocybin reliably produce significantly altered states of consciousness with a variety of subjectively experienced effects. These include certain changes to perception, cognition, and affect,1 which we refer to here as the acute subjective effects of psychedelics. In recent years, psychedelics such as psilocybin have also shown considerable promise as therapeutic agents when combined with talk therapy, for example, in the treatment of major depression or substance use disorder.2 However, it is currently unclear whether the aforementioned acute subjective effects are necessary to bring about the observed therapeutic effects of psilocybin and other psychedelics. This uncertainty has sparked a lively—though still largely hypothetical—debate on whether psychedelics without subjective effects (“nonsubjective psychedelics” or “non-hallucinogenic psychedelics”) could still have the same therapeutic impact, or whether the acute subjective effects are in fact necessary for this impact to be fully realized.3,4,5.

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.

Background Classic psychedelics, such as psilocybin and LSD, evoke certain kinds of altered states of consciousness. Specific features of the experience, such as its allegedly ineffable nature, have been discussed as posing challenges to the informed consent process. A growing call for tailored informed consent documents (ICDs) in the psychedelic bioethics literature raises the question of how closely ICDs used in contemporary psychedelic trials reflect the concrete suggestions and proposals offered by psychedelic bioethicists.Methods In this article, we review ICDs from psilocybin clinical trials in the United States. Using a content analysis approach, we provide a systematic qualitative description of the ICDs which comprise our final sample (N = 28; 28 clinical trials across 13 unique sites). Coders demonstrated good reliability (κ =.683).Results Qualitative analyses revealed that most of the coding aligned with expectations based upon the psychedelics bioethics literature, such as the emphasis on mental health risks and physical risks in ICDs. Notably, psychedelic-specific codes (e.g., ineffability, therapeutic touch) did not appear as frequently in ICDs.Conclusions Scholars in psychedelic bioethics have called for the inclusion of a variety of potential risks and benefits in ICDs. It will be important to continue debating which elements are worth including in ICDs such that potential research participants are presented with the most salient factors relevant to their decision about joining a study. We provide a table of best practices applied by our sample of ICDs.

Do psychological traits predict philosophical views? We administered the PhilPapers Survey, created by David Bourget and David Chalmers, which consists of 30 views on central philosophical topics (e.g., epistemology, ethics, metaphysics, philosophy of mind, and philosophy of language) to a sample of professional philosophers (N = 314). We extended the PhilPapers survey to measure a number of psychological traits, such as personality, numeracy, well-being, lifestyle, and life experiences. We also included non-technical ‘translations’ of these views for eventual use in other populations. We found limited to no support for the notion that personality or demographics predict philosophical views. We did, however, find that some psychological traits were predictive of philosophical views, even after strict correction for multiple comparisons. Findings include: higher interest in numeracy predicted physicalism, naturalism, and consequentialism; lower levels of well-being and higher levels of mental illness predicted hard determinism; using substances such as psychedelics and marijuana predicted non-realist and subjectivist views of morality and aesthetics; having had a transformative or self-transcendent experience predicted theism and idealism. We discuss whether or not these empirical results have philosophical implications, while noting that 68% of our sample of professional philosophers indicated that such findings would indeed have philosophical value.

The psychedelic psilocybin has shown promise both as treatment for psychiatric conditions and as a means of improving well-being in healthy individuals. In some jurisdictions (e.g., Oregon, USA), psilocybin use for both purposes is or will soon be allowed and yet, public attitudes toward this shift are understudied. We asked a nationally representative sample of 795 US Americans to evaluate the moral status of psilocybin use in an appropriately licensed setting for either treatment of a psychiatric condition or well-being enhancement. Showing strong bipartisan support, participants rated the individual’s decision as morally positive in both contexts. These results can inform effective policy-making decisions around supervised psilocybin use, given robust public attitudes as elicited in the context of an innovative regulatory model. We did not explore attitudes to psilocybin use in unsupervised or non-licensed community or social settings.

Evidence suggests that psychedelics bring about their therapeutic outcomes in part through the subjective or qualitative effects they engender and how the individual interprets the resulting experiences. However, psychedelics are contraindicated for individuals who have been diagnosed with certain mental illnesses, on the grounds that these subjective effects may be disturbing or otherwise counter-therapeutic. Substantial resources are therefore currently being devoted to creating psychedelic substances that produce many of the same biological changes as psychedelics, but without their characteristic subjective effects. In this article, we consider ethical issues arising from the prospect of such potential “nonsubjective” psychedelics. We are broadly supportive of efforts to produce such substances for both scientific and clinical reasons. However, we argue that such nonsubjective psychedelics should be reserved for those special cases in which the subjective effects of psychedelics are specifically contraindicated, whereas classic psychedelics that affect subjective experience should be considered the default and standard of care. After reviewing evidence regarding the subjective effects of psychedelics, we raise a number of ethical concerns around the prospect of withholding such typically positive, meaningful, and therapeutic experiences from most patients.

Psychedelics require cross-cultural, interdisciplinary study, and we were happy to see a contribution from the field of medical anthropology. Such a study holds the promise of characterizing the ways in which psychedelics are situated in contemporary societies, both within and beyond research and clinical contexts. Here, we offer some friendly criticism of the target article by Noorani while also highlighting various points of agreement and looking ahead to future research in this field.Noorani’s article is structured around an organizing theme of “containment.” The term is not formally defined, but functions more as a poetic metaphor, allowing the author to explore various ways in which psychedelics...