JAMA Network Open
June 3, 2024
Amy L. Mcguire, I Glenn Cohen, Dominic Sisti et al.
41 citations
A consensus statement from a 2023 meeting of 27 experts identifies 20 points of consensus across five ethical issues for integrating psychedelic medicines into mainstream medical practice: reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping. The meeting included clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists. The statement focuses on government-approved medical use in the US and abroad, emphasizing that policymakers must address challenges ahead while acknowledging the hopeful moment.
Neuroethics
June 20, 2024
Logan Neitzke-Spruill, Caroline Beit, Jill O. Robinson et al.
26 citations
Psychedelic experiences can be transformative, changing how people think and behave. In interviews with 26 participants in psychedelic retreats, 20 reported insights or experiences they believed were inaccessible without the drugs' psychoactive effects. All but one participant reported changes in identity, values, beliefs, desires, or behavior, with behavioral changes being most common. Participants felt capable of deciding to use psychedelics partly because they sought information beforehand. Several reported an enhanced ability to make changes in their lives. The findings highlight the importance of subjective embodiment and personal agency in shaping outcomes, raising neuroethical issues about consent and moral psychopharmacology.
Perspectives in biology and medicine
January 1, 2024
Brent M Kious, Andrew Peterson, Amy L. Mcguire
21 citations
Psychedelic substances hold promise for treating many conditions, but some argue that informed consent for their use may be impossible because psychedelic experiences can be transformative in the sense defined by L. A. Paul—involving knowledge that cannot be obtained otherwise or changes in the self. This article argues that there is limited evidence that psychedelic experiences are transformative in Paul's sense, and they may not differ in transformative features from other common medical experiences where informed consent is clearly possible. Even if psychedelic experiences can be transformative, informed consent remains possible. The article closes with recommendations for how informed consent processes should reflect the distinct features of psychedelic experiences.
Science
April 27, 2023
Amy L. Mcguire, Holly Fernandez Lynch, Lewis A. Grossman et al.
20 citations
Policy should facilitate the production of evidence regarding the safety and effectiveness of interventions.
The American journal of bioethics : AJOB
January 1, 2025
Logan Neitzke-Spruill, Caroline Beit, Lynnette A. Averill et al.
19 citations
The FDA rejected Lykos Therapeutics' application for MDMA-assisted therapy for PTSD in August 2024, partly due to a highly publicized case of alleged sexual misconduct by an unlicensed therapist during a Phase 2 trial. Several other cases of misconduct by facilitators at psychedelic retreats have raised questions about whether physical contact is ever appropriate during psychedelic-assisted therapy. Drawing on research about supportive touch in other clinical settings and considering features of psychedelics that increase the potential for harm, the authors advocate for a precautionary approach to harm-reduction while arguing that supportive touch should not be entirely discarded.
Psychiatr Res Clin Pract
February 11, 2025
Jules Evans, Marc Aixalà, Brian T Anderson et al.
18 citations
Thirty psychedelic researchers identified critical gaps in knowledge about harms from psychedelic use, including how to define those harms, predict them, and treat them effectively. They recommend better online information, peer support groups, affordable therapy, and psychiatric consultation for people experiencing post-psychedelic difficulties. The researchers also call for improved funding for a psychedelic safety net, suggesting that psychedelic philanthropists, investors, and companies commit 1% of their investment to support safety measures such as research and support services. The article outlines practical steps to make the field of psychedelic medicine safer.
PLoS One
May 2, 2025
Nikita Singh, Srijith Kambala, Logan Neitzke-Spruill et al.
10 citations
Public interest in psychedelics and adult use has grown alongside research into their clinical potential. A landscape analysis of online, publicly available information identified 298 organizations offering psychedelic retreats to English-speaking consumers between July and December 2023. Most organizations focused on general wellness rather than religious identity. Ayahuasca was the most commonly offered substance, followed by psilocybin and San Pedro. Retreats were held at 440 distinct physical locations worldwide, with 130 inside the United States and 310 outside. Prices varied widely. Further research into retreat practices is recommended to reduce harm and support consumer education.
Perspectives in biology and medicine
January 1, 2024
Logan Neitzke-Spruill, Neşe Devenot, Dominic Sisti et al.
7 citations
Psychedelics are again being studied for their traditional uses, medical applications, and social implications. As evidence for their clinical potential grows, researchers seek mechanisms explaining psychedelic effects and therapeutic efficacy. This paper reviews three frameworks—neurobiological, psychological, and spiritual—for understanding these effects and explores their implications for ethics and professional competencies in psychedelic medicine. The authors suggest interdisciplinary education to improve communication, develop multi-level models, and foster collaboration. They caution against overemphasizing neuro-mechanisms, risks from inducing vulnerable states, and challenges integrating spiritual frameworks. Developing new models that reflect emerging knowledge is a central goal for psychedelic science.
JAMA Netw Open
January 2, 2026
Amy L. Mcguire, Logan Neitzke-Spruill, Jill O. Robinson et al.
4 citations
Psychedelic retreat organizations vary widely in their safety precautions. All 49 organizations interviewed collected participant medical histories, and 73.5% excluded individuals with certain health conditions. Most required or recommended medication washout periods ranging from one day to over six weeks. While 69.4% worked with a licensed health care professional or someone with emergency response training, only 65.3% had such personnel in attendance at retreats at least some of the time. All organizations offered integration support. The variability in practices, particularly around medication washout and polysubstance use, may increase risks to participants. Best practice guidelines are needed and should be codeveloped with Indigenous and nonclinical communities.
J Affect Disord
May 16, 2026
David S. Mathai, Madeleine Cluck, Amna M. Aslam et al.
1 citation
A panel of experts from the American Society of Ketamine Physicians, Psychotherapists, and Practitioners used a Delphi process to develop consensus guidelines for administering intravenous ketamine infusions to treat depressive disorders. The guidelines provide recommendations on patient selection, dosing, safety monitoring, and treatment protocols, aiming to standardize clinical practice and improve patient outcomes. The consensus reflects agreement among specialists on best practices for this off-label use of ketamine.
Translational Behavioral Medicine
January 1, 2026
Joshua Mitchell, Logan Neitzke-Spruill, David S. Mathai et al.
1 citation
Clinical investigators anticipate that psychedelic medicine, including MDMA and psilocybin, could eventually fit into routine clinical care and may even improve it, despite distinct challenges. These treatments differ from existing ones in drug effects, treatment models, and broader goals. Key translational challenges include uncertainty about the role of psychotherapy, high treatment costs and scalability issues, and the effects of hype and stigma on clinical uptake. The findings are based on interviews with 21 investigators at major academic psychedelic research centers across the United States.
Brazilian Journal of Psychiatry
January 1, 2025
David S. Mathai, Jill O. Robinson, Kevin Wagner et al.
1 citation
Among 2,639 Hispanic and Latin American adults with obsessive-compulsive disorder (OCD) living across the Americas, 9% reported using psychedelics or related substances for treatment. Most (72%) had received traditional treatments like psychiatric medication or psychotherapy. Psilocybin, LSD, and MDMA were the most used psychedelics. Users were more likely to be male, have received non-ERP therapy, and have a comorbid psychiatric diagnosis. Outcomes for OCD symptoms varied widely by drug and were difficult to predict, but were most favorable for classic serotonergic psychedelics. Real-world evidence suggests Hispanic and Latin American adults are exploring psychedelics as a treatment for OCD, though further research is needed to establish safe and effective use.
Psychiatric services (Washington, D.C.)
July 1, 2026
Joshua Mitchell, Benjamin Bregman, Renuka Surujnarain et al.
Telehealth platforms expanded access to mental health care during the COVID-19 pandemic, including online prescribing of ketamine for off-label psychiatric use. A wrongful death lawsuit against a telehealth ketamine provider illustrates how combining off-label prescribing with on-demand delivery can weaken clinical safeguards. With limited oversight of many telehealth platforms and the drugs they prescribe, responsibility for patient safety falls heavily on clinicians. To sustain responsible care, structures must support robust clinical relationships, monitoring, and accountability.
Psychedelic Medicine
April 23, 2026
Jill Oliver Robinson, Ruiying (aria) Xiong, Logan Neitzke-Spruill et al.
A survey of 212 US institutional review board (IRB) chairs found that many lack knowledge about psychedelic risks and benefits, with 35–51% reporting gaps. Most chairs expressed neutral attitudes toward psychedelics (35–47%) and similar confidence reviewing psychedelic and nonpsychedelic protocols (61–78%). However, 33–53% reported heightened concern about psychedelic administration research, including legal, employment, and social risks, participant safety, consent challenges, and vulnerable populations. About half (47.2%) saw heightened institutional risk. Most (82.9%) agreed with requiring extensive monitoring of psychedelic sessions, but views on other protections varied widely. The findings suggest IRBs are not broadly conservative but uncertain, with concerns mirroring unsettled issues in the field.