A psychedelic renaissance is currently taking place in mental healthcare. The number of psychedelic-assisted therapy trials is growing steadily, and some countries already grant psychiatrists special permission to use psychedelics in non-research contexts under certain conditions. These clinical advances must be accompanied by ethical inquiry. One pressing ethical question involves whether patients can even give informed consent to psychedelic-assisted therapy: the treatment’s transformative nature seems to block its assessment, suggesting that patients are unable to understand what undergoing psychedelic-assisted therapy actually (...) means for them and whether it aligns with their values. The present paper argues that patients often have sufficient knowledge to give informed consent because they know that they want to change their negative status quo and that psychedelic-assisted therapy offers an effective way to do so. Accordingly, patients can understand what the transformative nature of psychedelic-assisted therapy means for them and a make a value-aligned choice even if they are unable to anticipate the manifestation of a psychedelic experience. (shrink)

In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses a major problem to informed consent. (...) The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

Background: Psychedelics are known for their powerful mental effects due to the activation of 5HT-2A receptors in the brain. During the 1950s and 1960s, research was conducted on these molecules until their criminalization. However, their clinical investigation as therapeutic tools for psychiatric disorders has revived the deontological ethics surrounding this subject. Questions arise as research on their therapeutic outcome becomes a reality. We aim to explore deontological ethics to understand the implications of psychedelics for the clinician, patient, and society. Results: (...) A total of 42 articles were considered for this review. Methods: A methodological search of psychedelic studies from 2017 to 2022 was conducted in PubMed, Scopus, EBSCOhost, and ScienceDirect to address the deontological ethics of clinical psychedelic use. Conclusion: Psychedelics need to be culturally contextualized, epistemic harm minimized and represented to ensure informed consent. Open data and commissions are needed to ensure safe and equal distribution. (shrink)

In their target article, Peterson et al. discuss the intriguing prospect of using psychedelics as a treatment for patients with Alzheimer’s Disease and Related Dementias (AD/ADRD) (Peterson et al....

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. (shrink)

Moral enhancement proposals struggle to be both plausible and ethically defensible while nevertheless interestingly distinct from both cognitive enhancement as well as (mere) moral education. Brian Earp (_Royal Institute of Philosophy Supplement_ 83:415–439, 12 ) suggests that a promising middle ground lies in focusing on the (suitably qualified) use of psychedelics as _adjuncts_ to moral development. But what would such an adjunctive use of psychedelics look like in practice? In this paper, I draw on literature from three areas where techniques (...) for moral development have been discussed: psychotherapy (e.g., Overholser 2010; Burns 1980) education (e.g., Uhl and Lütge, 2018), and AI-assisted enhancement (e.g., Lara and Deckers, _Neuroethics_ 13(3):275–287, 17 ) in order to propose more concrete ways in which to use psychedelics as adjuncts to moral development. It is shown that in each of these areas, we can see that _trusting_ relationships (e.g., Baier 1986; Hawley 2019) between the facilitator and the agent will very plausibly maximize the success of this type of moral enhancement. Finally, I appeal to literature on informed consent for use of psychedelics (e.g., Smith and Sisti, _Journal of Medical Ethics_, 22 ; Johnson et al., _The Journal of Psychopharmacology_ 22(6):603–20, 23 ) and on the therapeutic relationship in psychotherapy (e.g., Dryden and Reeves 2013; Horvath et al. 2011) to outline concrete suggestions for facilitating dimensions of trust most likely to maximize the benefits of (adjunctive) psychedelic moral enhancement. The result is a newly detailed practical proposal for how we might best facilitate moral enhancement by using drugs as adjuncts to moral development. (shrink)

In this opinion piece we propose the investigation of psychedelic-assisted psychotherapy for the treatment of body dysmorphic disorder (BDD). BDD is a psychiatric disorder characterised by appearance-based preoccupations and accompanying compulsions. While safe and effective treatments for BDD exist, non-response and relapse rates remain high. Therefore, there is a need to investigate promising new treatment options for this highly debilitating condition. Preliminary evidence suggests safety, feasibility, and potential efficacy of psychedelic treatments in disorders that share similar psychopathological mechanisms with BDD. (...) Drawing on this evidence, as well as on relevant qualitative reports and theoretical proposals, we argue that it would be worthwhile to conduct a phase 2a study aimed at assessing the safety and feasibility of psychedelic-assisted psychotherapy in BDD. We also offer some suggestions for how future research ought to proceed. (shrink)

Serotonergic (or “classic”) psychedelics have struck many researchers as raising significant philosophical questions that, until recently, were largely unexplored by academic philosophers. This paper provides an overview of four emerging lines of research at the intersection of academic philosophy and psychedelic science that have gained considerable traction in the last decade: selfless consciousness, psychedelic epistemology, psychedelic ethics, and spiritual/religious naturalism. In this paper, we highlight philosophical questions concerning (i) psychedelics, self-consciousness, and phenomenal consciousness, (ii) the epistemic profile of the psychedelic (...) experience; (iii) ethical concerns about the appropriate use of psychedelics; and (iv) whether spiritual or religious dimensions of psychedelic use are compatible with a naturalistic worldview. (shrink)

Historically, laws and policies to criminalize drug use or possession were rooted in explicit racism, and they continue to wreak havoc on certain racialized communities. We are a group of bioethicists, drug experts, legal scholars, criminal justice researchers, sociologists, psychologists, and other allied professionals who have come together in support of a policy proposal that is evidence-based and ethically recommended. We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate legal regulation. We (...) also call for criminal convictions for nonviolent offenses pertaining to the use or possession of small quantities of such drugs to be expunged, and for those currently serving time for these offenses to be released. In effect, we call for an end to the “war on drugs.”. (shrink)

This paper explores how transformative experience generates decision-making problems of particular seriousness in medical settings. Potentially transformative experiences are especially likely to be encountered in medicine, and the associated decisions are confronted jointly by patients and clinicians in the context of an imbalance of power and expertise. However in such scenarios the principle of informed consent, which plays a central role in guiding clinicians, is unequal to the task. We detail how the principle’s assumptions about autonomy, rationality and information handle (...) transformative experiences poorly, appealing to several difficult cases for medical decision-making to illustrate the resulting problem, and we consider how the existing literature on complications with consent fails to offer a resolution. We argue that recognition of the problem has a role to play in achieving a more effective response to transformative decisions. In Sect. 1 we introduce several representative cases of challenging patient decision-making that clinicians might face. In Sect. 2 we detail how transformative experience has been analysed in the recent literature, before outlining in Sect. 3 the theoretical basis of the principle of informed consent, which plays a central role in how clinicians are expected to support decision-making. In Sect. 4, having laid the groundwork for a clear description, we return to the cases given in Sect. 1 to confirm how their transformative nature presents a problem: either clinicians treat the decisions faced by these patients as ‘normal’, encouraging them to focus on information provision that patients may be unable to act on, or they treat them as transformative, in which case they lack the resources to recognise whether they are helping patients make (subjectively) good decisions. In Sect. 5 we argue that the existing literature does not offer any escape from this problem. We close in Sect. 6 by noting the significant impact that appreciating the problem of transformative experience could have on supporting transformative decisions in medicine and briefly suggesting how we might aim to develop new approaches to dealing with these. (shrink)

Psychedelics are experiencing a renaissance in mental healthcare. In recent years, more and more early phase trials on psychedelic-assisted therapy have been conducted, with promising results overall. However, ethical analyses of this rediscovered form of treatment remain rare. The present paper contributes to the ethical inquiry of psychedelic-assisted therapy by analysing the ethical implications of its therapeutic mechanisms proposed by the relaxed beliefs under psychedelics (REBUS) hypothesis. In short, the REBUS hypothesis states that psychedelics make rigid beliefs revisable by increasing (...) the influence of bottom-up input. Put differently, patients become highly suggestible and sensitive to context during a psychedelic session, amplifying therapeutic influence and effects. Due to that, patients are more vulnerable in psychedelic-assisted therapy than in other therapeutic interventions; they lose control during a psychedelic session and become dependent on the therapeutic setting (including the therapist). This enhanced vulnerability is ethically relevant and has been exploited by some therapists in the past. Therefore, patients in current research settings and starting mainstream medical settings need to be well informed about psychedelics’ mechanisms and their implications to give valid informed consent to treatment. Furthermore, other security measures are warranted to protect patients from the vulnerability coming with psychedelic-assisted therapy. (shrink)

In the historical context of a crisis in biological psychiatry, psychedelic drugs paired with psychotherapy are globally re-emerging in research clinics as a potential transdiagnostic therapy for treating mood disorders, addictions, and other forms of psychological distress. The treatments are poised to soon shift from clinical trials to widespread service delivery in places like Australia, North America, and Europe, which has prompted ethical questions by social scientists and bioethicists. Taking a broader view, we argue that the ethics of psychedelic therapy (...) concerns not simply how psychotherapies are different when paired with psychedelic drugs, but how psychedelic therapies shape and are shaped by different values, norms, and metaphysical commitments. Drawing from the published literature and interviews with seven psychedelic therapists working in clinical trials in the United States, Germany, Switzerland, and Australia, this article opens the black box of the treatments to consider the values and informal debates currently animating the therapies. Considering questions of patient autonomy, mechanisms of therapeutic action, and which therapies are best suited to pair with psychedelic substances, we examine the ethics of psychedelic therapy as an emergent form of life. To bring this form of life out in fuller relief, we conclude by comparing and contrasting it with ayahuasca use in Amazonian shamanism. (shrink)

Peterson et al. (2023) present a range of ethical issues that arise when considering the use of psychedelic substances within medicine. But psychedelics are, by their nature, boundary-dissolving, a...

Eating disorders are debilitating diseases that have twin impacts on the body and mind and are associated with a number of physiological and psychological comorbidities (Blinder, Cumella, and Sanathara 2006; Casiero and Frishman 2006), including increased suicide risk (Arcelus et al. 2011; Lipson and Sonneville 2020). In addition, eating disorders are growing in prevalence (Gilmache et al. 2019) and impact women at much higher rates than men (Bearman, Martinez, and Stice 2006), especially in adolescence (Spriggs, Kettner, and Carhart-Harris 2021). Anorexia (...) nervosa (AN) is a particularly devastating eating disorder, with one of the highest mortality rates of any psychiatric disorder (Sullivan 1995). Despite the severity of the condition, current treatments for AN are limited in their efficacy (Khalsa et al. 2017). Based on the growing body of evidence demonstrating the short-term and long-term efficacy of psychedelic-assisted psychotherapy for the treatment of other mental illnesses, I argue that research into psychedelic-assisted psychotherapy for AN should be funded. (shrink)

Psychedelic treatments, particularly 3,4-methylenedioxymethamphetamine (MDMA)-assisted and psilocybin-assisted therapies, have recently seen renewed interest in their clinical potential to treat various mental health conditions. Clinical trials for both MDMA-assisted and psilocybin-assisted therapies have shown to be highly efficacious for post-traumatic stress disorder and major depression. Recent research trials for psychedelic-assisted therapies (PAT) have demonstrated that although they are resource-intensive, their effects are rapid-acting, durable and cost-effective. These results have generated enthusiasm among researchers seeking to investigate psychedelic therapies in active-duty service members (...) of the US military, particularly those with treatment refractory mental health conditions. At the same time, psychedelics remain in early stages of clinical investigation, have not yet achieved regulatory approval for general clinical use and may confer unique psychological and neurobiological effects that could raise novel ethical considerations when treating active-duty service members. Should psychedelics achieve regulatory approval, military relevant considerations may include issues of access to these treatments, appropriate procedures for informed consent, confidentiality standards, and possible unanticipated mental health risks and other psychological sequelae. A service member’s deployability, as well as their ability to return to full military duty following PAT, may also be of unique concern. The authors argue that MDMA-assisted therapy currently represents a promising treatment that should be more rapidly investigated as a clinical therapy for service members while still taking a measured approach that accounts for the many military-specific uncertainties that remain. (shrink)

Both ethicists and lawyers accept that a provider – be it a researcher or a clinician – should provide sufficient information for a reasonable person to make an informed decision about whether they wish to go ahead with the proposed intervention or treatment.1 They are bound to do so both because they have an ethical responsibility to preserve the individual’s autonomous decision making, and, in many countries, because the law obliges them to. In this month’s issue of the JME, three (...) articles tackle ethical issues relating to consent in different contexts. Overarching these analyses is the pragmatic question of whether the process of taking consent in itself might alter the outcomes, and whether, in doing so, it can undermine the initial therapeutic or research goal – so creating another ethical question of what to prioritise. Psilocybin is entering Phase III trials to evaluate its effect on treatment resistant depression and cancer related depression and anxiety; earlier trials have shown sustained symptom reduction in these populations. Smith and Sisti examine whether a form of enhanced consent is ethically required for these drugs.2 They explore how to adequately consent for ‘therapeutic touch’ in a future altered state; the rare but significant mental health risks including trauma re-exposure; and the potential for a personality change given the intense experiences which many subjects have reported. They illustrate the potential for personality change with an example regarding the spiritual experiences which can occur with serotonergic psychedelics, and suggest that ‘agnostic or atheist patients may take the development of a newfound sense of spirituality or belief in God to …. (shrink)

The nascent for-profit psychedelic industry has begun to engage in corporate practices like funding scientific research and research programs. There is substantial evidence that such practices from other industries like tobacco, alcohol, pharmaceuticals and food create conflicts of interest and can negatively influence population health. However, in a context of funding pressures, low publicly funded success rates and precarious academic labor, there is limited ethics guidance for researchers working at the intersection of clinical practice and population health as to how (...) they should approach potential financial sponsorship from for-profit entities, such as the psychedelic industry. This article reports on a reflective exercise among a group of clinician scientists working in psychedelic science, where we applied Adams’ (2016) PERIL (Purpose, Extent, Relevant harm, Identifiers, Link) ethical decision-making framework to a fictionalized case of corporate psychedelic financial sponsorship. Our analysis suggests financial relationships with the corporate psychedelic sector may create varying degrees of risk to a research program’s purpose, autonomy and integrity. We argue that the commercial determinants of health provide a useful framework for understanding the ethics of industry-healthcare entanglements and can provide an important population health ethics lens to examine nascent industries such as psychedelics, and work toward potential solutions. (shrink)