Safety and patient well-being

Ensuring the safety and well-being of patients in psychedelic therapy is a fundamental ethical concern. Our analysis identified four related subthemes: (1) vulnerability of patients, (2) physical and psychological harm, (3) safety regulation, and (4) setting. Patient vulnerability emerged as the key ethical concept, while the other four subthemes represent contextual factors that impact the risk of harm. In psychedelic therapy, the subjective effects of psychedelics make patients particularly vulnerable to emotional distress, undue influence, inducement, sexual abuse, suggestibility, and various forms of exploitation (Anderson et al., Reference Anderson, Danforth and Grob2020; Azevedo et al., Reference Azevedo, Miguel and Madeira2023; Barber et al., Reference Barber, Nemeroff and Siegel2022; Barber & Dike, Reference Barber and Dike2023; Barnes, Reference Barnes1970; Barnett & Greer, Reference Barnett and Greer2021; Belouin et al., Reference Belouin, Averill, Henningfield, Xenakis, Donato, Grob, Berger, Magar, Danforth and Anderson2022; Brennan & Belser, Reference Brennan and Belser2022; Hall, Reference Hall2021; Harrison et al., Reference Harrison, Faber, Zare, Fontaine and Williams2025; Holka-Pokorska, Reference Holka-Pokorska2023; Siegel et al., Reference Siegel, Daily, Perry and Nicol2023; Simonsson et al., Reference Simonsson, Johnson and Hendricks2024; Thal et al., Reference Thal, Sharbanee, Skeffington, Baker, Bruno, Wenge and Bright2022; Wang et al., Reference Wang, Mathai, Gukasyan, Nayak and Garcia-Romeu2024; Williams et al., Reference Williams, Card and Faber2023).

Vulnerable patients might experience both physical harm and psychological harm. Assessment of adverse events has been lagging, and new frameworks are being created to identify risks and harms (Palitsky et al., Reference Palitsky, Kaplan, Perna, Bosshardt, Maples-Keller, Levin-Aspenson, Zarrabi, Peacock, Mletzko, Rothbaum, Raison, Grant and Dunlop2024). While the risks of dependence, abuse and neurotoxicity seem to be extremely low, especially for classic psychedelics like LSD or psilocybin (Johnson et al., Reference Johnson, Richards and Griffiths2008; Schlag et al., Reference Schlag, Aday, Salam, Neill and Nutt2022), there are cases of psychedelics triggering hallucinogen persisting perception disorder or psychosis in predisposed subjects (Scala et al., Reference Scala, Fabbri, Fusar-Poli, Di Lorenzo, Ferrara, Amerio, Fusar-Poli, Pichiecchio, Asteggiano, Menchetti, De Ronchi, Fanelli and Serretti2024; Schlag et al., Reference Schlag, Aday, Salam, Neill and Nutt2022). For this reason, there has been research for development of ‘non-hallucinogenic psychedelics’, in order to elicit many of the neurobiological changes without the subjective effects. Some ethical issues emerge from this discussion, for example, about whether psychedelics should be the default option if non-hallucinogenic psychedelics were an option (Cheung et al., Reference Cheung, Earp and Yaden2023; Poppe & Repantis, Reference Poppe, Repantis and Tomislav2024; Yaden et al., Reference Yaden, Earp and Griffiths2022; Zhang et al., Reference Zhang, Wang, Gao and Wang2024).

In order to mitigate the risks of psychedelics, the safety of both the therapeutic setting and the substances themselves is crucial. Given the powerful nature of psychedelic experiences, there is a need for clear safety measures and strict oversight regarding therapeutic environments, ensuring they are safe, supportive, and conducive to treatment (Villiger, Reference Villiger2024a, Reference Villiger2024b; Zhang et al., Reference Zhang, Wang, Gao and Wang2024). Controlled settings must include proper screenings, preparation, and support, and are therefore deemed safer compared to unregulated settings such as underground therapies, retreats or ceremonial use (Barber et al., Reference Barber, Nemeroff and Siegel2022; Jacobs, Murphy-Beiner, et al., Reference Jacobs, Yaden and Earp2023; Villiger, Reference Villiger2024a, Reference Villiger2024b). This is particularly problematic because of the risk that trial participants might attempt to replicate the experience after the trial ends (Jacobs, Murphy-Beiner, et al., Reference Jacobs, Yaden and Earp2023). However, some scholars recognize the value of a ritualistic context compared to a clinical setting, especially for substances with a long history of traditional use (Schenberg & Gerber, Reference Schenberg and Gerber2022).

Therapeutic relationships

The theme ‘Therapeutic relationships’ is composed of the following five subthemes: (1) trust and therapeutic alliance, (2) the professional ethics of therapists, (3) boundary issues, (4) transference and countertransference, and (5) training for psychedelic therapists. While the first two subthemes describe more conceptual aspects of therapeutic relationships, the latter three describe contextual aspects within the therapeutic relationship and the necessary training.

While a lot of issues pertaining to the therapeutic relationship are not unique to psychedelic-assisted therapy, the intense nature of the experiences facilitated by psychedelics causes additional risks and requires clear guidelines regarding professional ethics, both during and after the treatment or trial (Azevedo et al., Reference Azevedo, Miguel and Madeira2023; Rajwani, Reference Rajwani2023; Whinkin et al., Reference Whinkin, Opalka, Watters, Jaffe and Aggarwal2023) and after (Jacobs, Murphy-Beiner et al., Reference Jacobs, Yaden and Earp2023). A strong, trusting therapeutic alliance is essential, as patients often enter therapy in vulnerable states, requiring a therapist who can offer safety, empathy, and guidance throughout the process (Barnes, Reference Barnes1970; Ortiz et al., Reference Ortiz, Sweat, Garcia-Romeu, MacCarthy, Anderson and Hendricks2022).

Such a unique context presents higher risks of relational harm, sexual misconduct, abuse and exploitation, and raises concerns around maintaining professional boundaries, especially around therapeutic touch (Brennan & Belser, Reference Brennan and Belser2022; Harrison et al., Reference Harrison, Faber, Zare, Fontaine and Williams2025; Herpers et al., Reference Herpers, Maximets, van Dongen, Zijlmans and Vermetten2024; Jacobs, Earp, et al., Reference Jacobs, Earp, Appelbaum, Bruce, Cassidy, Celidwen, Cheung, Clancy, Devenot, Evans, Lynch, Friesen, Garcia-Romeu, Gehani, Maloof, Marcus, Moen, Mertens, Nayak and Yaden2024; McNamee et al., Reference McNamee, Nese and Buisson2023; Poppe & Repantis, Reference Poppe, Repantis and Tomislav2024). Such risks can be counterbalanced by employing two therapists of different genders for a session (Holka-Pokorska, Reference Holka-Pokorska2023), by establishing clear guidelines about what constitutes acceptable therapeutic touch (McGuire et al., Reference McGuire, Cohen, Sisti, Baggott, Celidwen, Devenot, Gracias, Grob, Harvey, Kious, Marks, Mithoefer, Nielson, Öngür, Pallas, Peterson, Schenberg, Summergrad, Waters and Yaden2024; McNamee et al., Reference McNamee, Nese and Buisson2023; Neitzke-Spruill et al., Reference Neitzke-Spruill, Beit, Averill and McGuire2025; Peacock et al., Reference Peacock, Brauer, Zarrabi, Dunlop, Maples-Keller, Grant, Raison, Rab and Palitsky2024; Sisti, Reference Sisti2024; Smith & Sisti, Reference Smith and Sisti2021), and by increasing awareness of the power imbalance between patient and therapist (Johnson, Reference Johnson2021; Lee et al., Reference Lee, Rosenbaum and Buchman2024; Peacock et al., Reference Peacock, Brauer, Zarrabi, Dunlop, Maples-Keller, Grant, Raison, Rab and Palitsky2024; Repantis et al., Reference Repantis, Koslowski and Fink2024). Psychodynamic concepts such as transference and countertransference, which describe the unconscious projection of feelings, including sexualized feelings, must be navigated carefully to protect both parties from relational harm and boundary violations (Anderson et al., Reference Anderson, Danforth and Grob2020; Jacobs, Reference Jacobs2023; Marcus, Reference Marcus2023; McNamee et al., Reference McNamee, Nese and Buisson2023; Phelps, Reference Phelps2017; Villiger & Trachsel, Reference Villiger and Trachsel2023). Because of the patient’s suggestible state, therapists should also be aware of the potential impact that their own beliefs and explanatory models can have on their patients, and exercise caution and epistemic humility both in regards to their understanding of the patient’s condition and to metaphysical stances such as materialism or spirituality (Borkel, Rojas-Hernández, Quintana-Hernández, & Henríquez-Hernández, Reference Borkel, Rojas-Hernández, Quintana-Hernández and Henríquez-Hernández2025; Caporuscio & Fink, Reference Caporuscio and Fink2024; Cohen & Marks, Reference Cohen and Marks2025; Jacobs, Earp, et al., Reference Jacobs, Earp, Appelbaum, Bruce, Cassidy, Celidwen, Cheung, Clancy, Devenot, Evans, Lynch, Friesen, Garcia-Romeu, Gehani, Maloof, Marcus, Moen, Mertens, Nayak and Yaden2024; Neitzke-Spruill et al., Reference Neitzke-Spruill, Devenot, Sisti, Averill and McGuire2024; O’Donnell et al., Reference O’Donnell, Grigsby and Grob2025; Poppe et al., Reference Poppe, Villiger, Repantis and Trachsel2025).

In addition, ensuring that therapists are properly trained in the clinical use of psychoactive substances is critical for the ethical delivery of psychedelic-assisted therapy (Barber & Dike, Reference Barber and Dike2023; Belouin et al., Reference Belouin, Averill, Henningfield, Xenakis, Donato, Grob, Berger, Magar, Danforth and Anderson2022); however, some aspects of the training are still being debated, and psychedelic trainings often show inconsistent practices and standards of care (Destoop et al., Reference Destoop, Mohr, Butlen, Kéri, Samochowiec, De Picker, Fiorillo, Kuypers and Dom2025; Perez Rosal et al., Reference Perez Rosal, La Torre, Birnkammer, Chernoloz, Williams and Faber2024; Poppe & Repantis, Reference Poppe, Repantis and Tomislav2024; Sisti, Reference Sisti2024). For example, it is unclear whether therapists’ prior experience with psychedelics should be encouraged or even included as part of the training and to what extend this can or should be disclosed (Anderson et al., Reference Anderson, Danforth and Grob2020; Azevedo et al., Reference Azevedo, Miguel and Madeira2023; Barber et al., Reference Barber, Nemeroff and Siegel2022; Barber & Dike, Reference Barber and Dike2023; Barnes, Reference Barnes1970; Barnett & Greer, Reference Barnett and Greer2021; Belouin et al., Reference Belouin, Averill, Henningfield, Xenakis, Donato, Grob, Berger, Magar, Danforth and Anderson2022; Brennan & Belser, Reference Brennan and Belser2022; Emmerich & Humphries, Reference Emmerich and Humphries2023; Hall, Reference Hall2021; Holka-Pokorska, Reference Holka-Pokorska2023; King & Hammond, Reference King and Hammond2021; Pilecki et al., Reference Pilecki, Luoma, Bathje, Rhea and Narloch2021; Siegel et al., Reference Siegel, Daily, Perry and Nicol2023; Smith & Appelbaum, Reference Smith and Appelbaum2022; Thal et al., Reference Thal, Sharbanee, Skeffington, Baker, Bruno, Wenge and Bright2022; Williams et al., Reference Williams, Card and Faber2023; Wilson-Poe et al., Reference Wilson-Poe, Hoffman, Pertl, Luoma, Bazinet, Stauffer, McCarty and Korthuis2024).

Informed consent

As a cornerstone of ethical clinical practice, the theme of ‘Informed consent’ involves both conceptual and contextual dimensions, which are captured in four subthemes: (1) disclosure, (2) decision-making capacity, (3) challenges, and (4) potential solutions.

Informed consent is rendered particularly problematic by the profound psychological effects of psychedelics and clear and thorough disclosure of potential risks and benefits is essential (Barber & Dike, Reference Barber and Dike2023; Barnes, Reference Barnes1970; Edelsohn & Sisti, Reference Edelsohn and Sisti2023; Jacobs, Earp, et al., Reference Jacobs, Earp, Appelbaum, Bruce, Cassidy, Celidwen, Cheung, Clancy, Devenot, Evans, Lynch, Friesen, Garcia-Romeu, Gehani, Maloof, Marcus, Moen, Mertens, Nayak and Yaden2024; Mathai et al., Reference Mathai, Lee, Mora, O’Donnell, Garcia-Romeu and Storch2022; Ortiz et al., Reference Ortiz, Sweat, Garcia-Romeu, MacCarthy, Anderson and Hendricks2022; Pilecki et al., Reference Pilecki, Luoma, Bathje, Rhea and Narloch2021). This can be rendered complex by the unpredictability of the effects, not only during the acute phase of the experience but also at the level of long-term personal transformation and belief change (Anderson et al., Reference Anderson, Danforth and Grob2020; Barber & Dike, Reference Barber and Dike2023; Egerton & Capitelli-McMahon, Reference Egerton and Capitelli-McMahon2023; Emmerich & Humphries, Reference Emmerich and Humphries2023; Haeusermann & Chiong, Reference Haeusermann and Chiong2024; Jacobs, Reference Jacobs2023; Jacobs, Earp, et al., Reference Jacobs, Earp, Appelbaum, Bruce, Cassidy, Celidwen, Cheung, Clancy, Devenot, Evans, Lynch, Friesen, Garcia-Romeu, Gehani, Maloof, Marcus, Moen, Mertens, Nayak and Yaden2024; Jacobs, Murphy-Beiner, et al., Reference Jacobs, Murphy-Beiner, Rouiller, Nutt and Spriggs2024; Repantis et al., Reference Repantis, Koslowski and Fink2024; Villiger, Reference Villiger2024a, Reference Villiger2024b). Decision-making capacity must be assessed to ensure that participants are fully able to understand and consent to the therapy, free from coercion or undue influence. This is especially complicated during the acute experience, due to the strong subjective effects (Cheung et al., Reference Cheung, Earp and Yaden2023; Lee et al., Reference Lee, Rosenbaum and Buchman2024; O′ Brien & Nutt, Reference O’Brien and Nutt2025; Otterman, Reference Otterman2023; Peterson et al., Reference Peterson, Largent, Lynch, Karlawish and Sisti2023; Poppe & Repantis, Reference Poppe, Repantis and Tomislav2024; Rosenbaum, Cho, et al., Reference Rosenbaum, Cho, Schneider, Hales and Buchman2023; Sisti et al., Reference Sisti, Segal and Thase2014; Villiger, Reference Villiger2024a, Reference Villiger2024b).

Other challenges include managing expectations (Elman et al., Reference Elman, Pustilnik and Borsook2022), accounting for cultural differences that might create misunderstandings during the session, include provisions in case patients decide to leave the session during an altered state of consciousness, and surrogate decision-making (Azevedo et al., Reference Azevedo, Miguel and Madeira2023). For these reasons, the psychedelic field might benefit from developing guidelines and requirements for ‘enhanced consent’ under psychedelics (Cohen & Marks, Reference Cohen and Marks2025; Destoop et al., Reference Destoop, Mohr, Butlen, Kéri, Samochowiec, De Picker, Fiorillo, Kuypers and Dom2025; Marks et al., Reference Marks, Brendel, Shachar and Cohen2024; Smith & Sisti, Reference Smith and Sisti2021; Tustison et al., Reference Tustison, Niemi and Choi2025).

Equity and access

The overarching theme of ‘Equity and access’ is constituted by three distinct subthemes: (1) inequity, (2) accessibility, and (3) compassionate use. The subtheme of inequity provides the central conceptual framework for this domain. The subsequent subthemes delineate the primary contexts in which inequities manifest through issues of accessibility, specific barriers to treatment, challenges in real-world access, and the particular case of compassionate use programs.

Equity and access concerns are paramount in ensuring that vulnerable populations are not ‘left behind’ in the current and future provision of psychedelic-assisted therapies. These include patients from low-income backgrounds, rural areas, or underserved racial and ethnic communities. González Romero (Reference González Romero2023) argues that the right to health and cognitive liberty includes a right to psychedelic-assisted treatments: if psychedelic-assisted treatments become available, they should be accessible to everyone who can benefit (Destoop et al., Reference Destoop, Mohr, Butlen, Kéri, Samochowiec, De Picker, Fiorillo, Kuypers and Dom2025). However, equitable access is limited due to social, logistical and financial barriers (Barlett et al., Reference Bartlett, Christ, Martins, Saxberg and Ching2024; Jacobs, Earp, et al., Reference Jacobs, Earp, Appelbaum, Bruce, Cassidy, Celidwen, Cheung, Clancy, Devenot, Evans, Lynch, Friesen, Garcia-Romeu, Gehani, Maloof, Marcus, Moen, Mertens, Nayak and Yaden2024; Poppe & Repantis, Reference Poppe, Repantis and Tomislav2024). Most psychedelic-assisted therapy protocols are time-intensive, rendering them difficult to access for vulnerable populations with limited resources, especially when the compensation is low or nonexistent (Ortiz et al., Reference Ortiz, Sweat, Garcia-Romeu, MacCarthy, Anderson and Hendricks2022); a problem that might get worse after approval if psychedelic-assisted treatments are not approved for medical insurance reimbursement (Barnett & Greer, Reference Barnett and Greer2021; Noorani, Reference Noorani2020; Rea & Wallace, Reference Rea and Wallace2021).

In addition to the financial barriers, literacy levels are an issue: psychedelic experiences are often difficult to characterize, and the technical language normally used might obscure comprehension, leading to experiences of powerlessness that may hinder effective informed consent procedures and affect participants’ willingness to participate (Ortiz et al., Reference Ortiz, Sweat, Garcia-Romeu, MacCarthy, Anderson and Hendricks2022). Another issue is the lack of widespread availability, particularly in marginalized communities, creating inequities in treatment access that may lead to less safe and less effective underground use (Barber et al., Reference Barber, Nemeroff and Siegel2022; Smith & Appelbaum, Reference Smith and Appelbaum2022), for which especially people of color face greater legal risks (Campbell & Williams, Reference Campbell and Williams2021). Another question is whether psychedelics should be made available together with other forms of mental health support in prison settings (Bayrhammer-Savel et al., Reference Bayrhammer-Savel, Ortner, Van Hout and Komorowski2024). Some of these problems may be remedied by representing marginalized communities at the level of patients, medical professionals, and researchers, to foster a more inclusive environment (Barber et al., Reference Barber, Nemeroff and Siegel2022; Haeusermann & Chiong, Reference Haeusermann and Chiong2024; Lee et al., Reference Lee, Rosenbaum and Buchman2024; Miceli McMillan, Reference Miceli McMillan2022; Ona et al., Reference Ona, Kohek and Bouso2022; Ortiz et al., Reference Ortiz, Sweat, Garcia-Romeu, MacCarthy, Anderson and Hendricks2022; Rea & Wallace, Reference Rea and Wallace2021; Rosa, Reference Rosa2022; Whinkin et al., Reference Whinkin, Opalka, Watters, Jaffe and Aggarwal2023; Williams et al., Reference Williams, Card and Faber2023). Cost-saving and access-promoting approaches include group therapy and short-acting psychedelics (Barber & Dike, Reference Barber and Dike2023).

Accessibility for patients resistant to other forms of treatment should be priority. Compassionate use programs, designed to provide treatments outside of clinical trials for those without alternative options, may offer solutions but also pose questions about fairness and safety (Campbell & Williams, Reference Campbell and Williams2021; Greif & Šurkala, Reference Greif and Šurkala2020; Hall, Reference Hall2021).

Research ethics

We delineated eight subthemes for research ethics. Four are core ethical concepts: (1) clinical equipoise, (2) risk and benefit analysis, (3) research integrity, and (4) social value. The other four are contextual factors specific to psychedelic research: (5) research policy, (6) vulnerable groups, (7) unique methodological challenges, and (8) the limited evidence base.

A predominant subtheme that emerged from our analysis on research ethics was the importance of research policy. This includes criticism to the Food and Drug Administration and other regulators limiting the freedom of use and research of Schedule I substances (Andreae et al., Reference Andreae, Rhodes, Bourgoise, Carter, White, Indyk, Sacks and Rhodes2016) and arguments for the right to early access to promising experimental therapies for patients with mental illnesses (Black, Reference Black2023; Campbell & Williams, Reference Campbell and Williams2021). Research integrity is also a common concern, including researcher bias (Kious et al., Reference Kious, Schwartz and Lewis2023; Oliveira-Maia & Seybert, Reference Oliveira-Maia and Seybert2024; Tang, Reference Tang2024), worries about the appropriation of publicly funded knowledge by the private sector (Ona et al., Reference Ona, Kohek and Bouso2022), and calls for more public, independent research (Hall, Reference Hall2021). Andreae et al. (Reference Andreae, Rhodes, Bourgoise, Carter, White, Indyk, Sacks and Rhodes2016) point out a lack of ethics guidelines on the conduct of studies with schedule I substances, while Da Costa and Sofuoglu (Reference da Costa and Sofuoglu2023) mention the need for independent review and potential biases of research ethics committees toward experimentation with psychedelics. Many of the problems compromising the validity of psychedelic research can be attributed to its unique methodological challenges, including difficulties in trial design, expectancy effects, and unblinding (Destoop et al., Reference Destoop, Mohr, Butlen, Kéri, Samochowiec, De Picker, Fiorillo, Kuypers and Dom2025; Iserson, Reference Iserson2019; Matvey et al., Reference Matvey, Kelley, Bradley, Chiong, O’Donovan and Woolley2025; Oliveira-Maia & Seybert, Reference Oliveira-Maia and Seybert2024; Scala et al., Reference Scala, Fabbri, Fusar-Poli, Di Lorenzo, Ferrara, Amerio, Fusar-Poli, Pichiecchio, Asteggiano, Menchetti, De Ronchi, Fanelli and Serretti2024).

Another key topic related to research ethics concerns harm to participants. The unpredictability of psychedelic effects and the insufficient data regarding the clinical and social values of psychedelic research (Bodnár & Kakuk, Reference Bodnár and Kakuk2019; da Costa & Sofuoglu, Reference da Costa and Sofuoglu2023; Peterson et al., Reference Peterson, Timmermann and Weijer2019) makes the risk/benefit ratio complex to calculate (Bodnár & Kakuk, Reference Bodnár and Kakuk2019; O′ Brien & Nutt, Reference O’Brien and Nutt2025). Furthermore, the unpredictability of psychedelic trials and the hype around them might have an impact on the capacity to obtain informed consent for safeguarding of participants’ autonomy (Andreae et al., Reference Andreae, Rhodes, Bourgoise, Carter, White, Indyk, Sacks and Rhodes2016; Bodnár & Kakuk, Reference Bodnár and Kakuk2019). It is also important to respect the right of participants to withdraw from the study (Bodnár & Kakuk, Reference Bodnár and Kakuk2019).

It is also crucial to consider issues pertaining to justice in research, for example, how vulnerable groups might be affected by the way psychedelic research is conducted. There is a duty to facilitate research engagement among marginalized populations (Bodnár & Kakuk, Reference Bodnár and Kakuk2019), to counteract the underrepresentation of people of color (Azevedo et al., Reference Azevedo, Miguel and Madeira2023; Barber & Dike, Reference Barber and Dike2023; Edelsohn & Sisti, Reference Edelsohn and Sisti2023; Elman et al., Reference Elman, Pustilnik and Borsook2022; George et al., Reference George, Michaels, Sevelius and Williams2020; Simon, Reference Simon2024), queer people (Bartlett et al., Reference Bartlett, Christ, Martins, Saxberg and Ching2024), and women (George et al., Reference George, Michaels, Sevelius and Williams2020) in psychedelic research. Furthermore, psychedelic research must come to terms with its history of unethical research (Edelsohn & Sisti, Reference Edelsohn and Sisti2023; Smith et al., Reference Smith, Faber, Buchanan, Foster and Green2022; Strauss et al., Reference Strauss, de la Salle, Sloshower and Williams2022; Zhang & Ho, Reference Zhang and Ho2017) and mitigate the risk of repeating past mistakes. For this reason, it is important to work toward equitable research practices and community-based participatory research (Williams et al., Reference Williams, Card and Faber2023).

Special contexts

For this contextual theme, the thematic analysis resulted in four subthemes of special contexts: (1) pediatric and adolescent patients, (2) military, (3) end of life, and (4) other conditions.

Different patient populations demand special ethical considerations. For pediatric and adolescent participants, questions arise around increased vulnerability, their capacity to assent to the treatment, and their parents’ authority to give consent for them (Edelsohn & Sisti, Reference Edelsohn and Sisti2023; Jeffrey et al., Reference Jeffrey, Weintraub and Grob2024; Sathappan & Yudkoff, Reference Sathappan and Yudkoff2024; Sutherland et al., Reference Sutherland, Ho and Croarkin2025). This is especially relevant for conditions that have a significant adolescent population, such as Anorexia Nervosa (Hu et al., Reference Hu, Lin, Wang and Wang2025; Lacroix et al., Reference Lacroix, Fatur, Hay, Touyz and Keshen2024; Otterman, Reference Otterman2023).

Patients with Alzheimer’s disease and other dementias might benefit from access to psychedelic-assisted therapy (Rudolph, Reference Rudolph2023; Zheng et al., Reference Zheng, Ma, Yang and Li2024), but these conditions magnify ethical issues relevant to broader psychedelic medicine, such as the impact of psychedelics on autonomy and consent, the impact of ‘ego dissolution’ on someone experiencing a pathology of self, the impact of psychedelics on caregiving, the effects of misleading public claims, and exaggerated hype on desperate patients (Peterson et al., Reference Peterson, Largent, Lynch, Karlawish and Sisti2023). Furthermore, since risk factors linked to dementia development are common among marginalized populations, there is a risk of perpetuating existing inequities (Rudolph, Reference Rudolph2023). Similar concerns apply to disorder of consciousness patients, whose consciousness is globally impaired for an extended period of time (Cardone et al., Reference Cardone, Alnagger, Annen, Bicego, Gosseries and Martial2024; Peterson et al., Reference Peterson, Timmermann and Weijer2019). This poses questions related to surrogate consent, risk/benefit analysis, and fair participant selection (Peterson et al., Reference Peterson, Timmermann and Weijer2019).

Military populations raise additional concerns (Wolfgang & Hoge, Reference Wolfgang and Hoge2023), such as considerations of confidentiality (i.e. that psychedelics might predispose a patient to divulge information that they would not have intended to (Hoener et al., Reference Hoener, Wolfgang, Nissan and Howe2023) and personality shifts due to treatment that may make it more difficult for service members to continue actively participating in war or combat (Hoener et al., Reference Hoener, Wolfgang, Nissan and Howe2023. There are also concerns of weaponization and military abuse of psychedelics (Germann, Reference Germann2019).

End-of-life care brings forth questions about the use of psychedelics to address existential distress, balancing relief of irremediable suffering with concerns about the safety and ethical administration of substances in terminal stages (Berens & Kim, Reference Berens and Kim2022; Cornish et al., Reference Cornish, Coles, Cheng, Sotomayor, Wolfgang and Spevak2025; Korkmaz et al., Reference Korkmaz, Cikrikcili, Akan and Yucesan2024; Masse-Grenier et al., Reference Masse-Grenier, Chang, Belanger, Stephan, Hebert, Deschamps, Plourde, Provost, Farzin, Fallu and Dorval2024; Plourde et al., Reference Plourde, Chang, Farzin, Gagnon, Hebert, Foxman, Deschamps, Provost, Masse-Grenier, Stephan, Cheung, Joly, Fallu and Dorval2024; Poppe & Repantis, Reference Poppe, Repantis and Tomislav2024; Somers & Scheepers, Reference Somers and Scheepers2025). One dilemma that is specific to end-of-life care regards authenticity in the case of patients changing their decision to seek medical assistance in dying following psychedelic-assisted therapy (Berens & Kim, Reference Berens and Kim2022; Rosenbaum, Hales, & Buchman, Reference Rosenbaum, Hales and Buchman2023; Somers & Scheepers, Reference Somers and Scheepers2025). If psychedelics get approved to treat non-psychiatric conditions, such as chronic pain, a thorough ethical assessment should address potential dilemmas before they arise (Robinson et al., Reference Robinson, Slitzky, Schatman, Yong, Lehman, Kaynar, Shivanekar and Emerick2024).

Societal and cultural implications

The societal and cultural implications of psychedelic-assisted therapy extend beyond the clinic. In the analysis, five subthemes were salient. They entailed both conceptual and contextual themes such as (1) interactions with non-clinical uses, (2) medicalization and unique regulatory challenges, (3) cultural sensitivity and inclusivity, (4) media and the public, and (5) artificial intelligence.

It is currently unclear what effect medicalization will have on psychedelic use outside of the clinic, where psychedelic substances are often consumed either recreationally or as a form of self-improvement. While some recognize the value of psychedelics outside the clinic, others worry about the lack of safety in such contexts, which could lead to social harms or undermine therapeutic benefits (Andrews et al., Reference Andrews, Hall, Humphreys and Marsden2025; Barber & Dike, Reference Barber and Dike2023; Letheby & Saja, Reference Letheby and Saja2022; Williams et al., Reference Williams, Card and Faber2023). Inclusivity and respect for indigenous traditions are key concepts. The increasing medicalization of psychedelics raises questions about the tension between therapeutic use and the broader cultural, spiritual, and traditional practices in which these substances have historically been embedded (Andrews & Wright, Reference Andrews and Wright2022; Belouin et al., Reference Belouin, Averill, Henningfield, Xenakis, Donato, Grob, Berger, Magar, Danforth and Anderson2022; Celidwen et al., Reference Celidwen, Githaiga, Calambás, Añaños, Chindoy, Vitale, Rojas, Mondragón, Vázquez Rosalío and Sacbajá2022; Cohen & Marks, Reference Cohen and Marks2025; Gerber et al., Reference Gerber, Flores, Ruiz, Ali, Ginsberg and Schenberg2021; McGuire et al., Reference McGuire, Cohen, Sisti, Baggott, Celidwen, Devenot, Gracias, Grob, Harvey, Kious, Marks, Mithoefer, Nielson, Öngür, Pallas, Peterson, Schenberg, Summergrad, Waters and Yaden2024; McMillan, Reference McMillan2021; Miceli McMillan, Reference Miceli McMillan2022; Neitzke-Spruill et al., Reference Neitzke-Spruill, Devenot, Sisti, Averill and McGuire2024; Noorani, Reference Noorani2020; Ona et al., Reference Ona, Kohek and Bouso2022; Rea & Wallace, Reference Rea and Wallace2021; Rudolph, Reference Rudolph2023; Whinkin et al., Reference Whinkin, Opalka, Watters, Jaffe and Aggarwal2023) and privatization and financial investments (Destoop et al., Reference Destoop, Mohr, Butlen, Kéri, Samochowiec, De Picker, Fiorillo, Kuypers and Dom2025). This includes more specific concerns of cultural appropriation, unequitable sharing of benefits, inaccessible costs for marginalized populations, and ecological concerns (Azevedo et al., Reference Azevedo, Miguel and Madeira2023; Celidwen et al., Reference Celidwen, Githaiga, Calambás, Añaños, Chindoy, Vitale, Rojas, Mondragón, Vázquez Rosalío and Sacbajá2022; Gerber et al., Reference Gerber, Flores, Ruiz, Ali, Ginsberg and Schenberg2021; Haeusermann & Chiong, Reference Haeusermann and Chiong2024; Hauskeller & Schwarz, Reference Hauskeller and Schwarz2023; King & Hammond, Reference King and Hammond2021; Labate et al., Reference Labate, de Assis, Gomes, Smith and Cavnar2022; Marcus, Reference Marcus2023; McMillan, Reference McMillan2021; Ona et al., Reference Ona, Kohek and Bouso2022; Peacock et al., Reference Peacock, Brauer, Zarrabi, Dunlop, Maples-Keller, Grant, Raison, Rab and Palitsky2024; Rea & Wallace, Reference Rea and Wallace2021; Rosa, Reference Rosa2022; Schenberg & Gerber, Reference Schenberg and Gerber2022; Williams et al., Reference Williams, Card and Faber2023) as well as intellectual property rights impeding indigenous access to psychedelics (Belouin et al., Reference Belouin, Averill, Henningfield, Xenakis, Donato, Grob, Berger, Magar, Danforth and Anderson2022; Celidwen et al., Reference Celidwen, Githaiga, Calambás, Añaños, Chindoy, Vitale, Rojas, Mondragón, Vázquez Rosalío and Sacbajá2022).

Additionally, public discourse and media portrayals of psychedelics must be carefully managed to avoid positive or negative exceptionalism about psychedelics, including misinformation, misrepresentation, hype, or stigmatization (Azevedo et al., Reference Azevedo, Miguel and Madeira2023; Barber et al., Reference Barber, Nemeroff and Siegel2022; Belouin et al., Reference Belouin, Averill, Henningfield, Xenakis, Donato, Grob, Berger, Magar, Danforth and Anderson2022; Beswerchij & Sisti, Reference Beswerchij and Sisti2022; Campbell & Williams, Reference Campbell and Williams2021; Cheung et al., Reference Cheung, Earp, Patch and Yaden2025; Cohen & Marks, Reference Cohen and Marks2025; Munafò et al., Reference Munafò, Arillotta, Mannaioni, Schifano, Bernardini and Cantarella2023; Noorani, Reference Noorani2020; O′ Brien & Nutt, Reference O’Brien and Nutt2025; Ona et al., Reference Ona, Kohek and Bouso2022; Peterson et al., Reference Peterson, Largent, Lynch, Karlawish and Sisti2023; Pilecki et al., Reference Pilecki, Luoma, Bathje, Rhea and Narloch2021; Ryan & Loo, Reference Ryan and Loo2017; Sandbrink et al., Reference Sandbrink, Johnson, Gill, Yaden, Savulescu, Hannikainen and Earp2024; Sisti, Reference Sisti2024).

Finally, the use of new technology, such as Artificial Intelligence, in combination with psychedelic-assisted treatments is likely to become an important topic in future years and ethical implications of it should be carefully assessed (Sarris et al., Reference Sarris, Halman, Urokohara, Lehrner and Perkins2024).