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.
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.
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.
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.
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.