While psychedelics are moving toward possible approval for clinical use for the treatment of mental disorders, the medical standards for integrating these substances into health care have lagged, according to a special report issued in JAMA Psychiatry.
Of particular concern is the establishment of norms for informed consent, an ethical and legal cornerstone of medicine, according to a special communication written by Mason Marks, M.D., J.D., of Florida State University; Rebecca W. Brendel, M.D., J.D., of Harvard Medical School; and colleagues.
“Psychedelics have unique properties that complicate the informed consent process. They often produce intense subjective experiences that are difficult to explain, predict, or comprehend, especially for psychedelic-naive individuals,” the authors wrote. “These effects can include profound perceptual changes or hallucinations, mood disturbances, paranoia, and an altered sense of self and reality.”
The authors proposed several essential components of informed consent that professionals need to address before administering psychedelics in clinical settings. These include the following:
- Advising patients about the potential for specific adverse events, such as acute and chronic perceptual changes, personality changes, and altered metaphysical beliefs.
- Establishing safeguards in advance of treatment around the potential use of limited physical touch in treatment, such as a reassuring touch of the shoulder.
- Advising about the increased risk of abuse, exploitation, or coercion during treatment and in the weeks or months after.
- Conveying the heightened social, legal, and professional risks associated with information that may be disclosed during a psychedelic state.
- Disclosing potential conflicts of interest or other relevant practitioner information.
- Creating more interactive education and consent processes to improve comprehension, such as consent quizzes to test knowledge or virtual reality content to simulate the experience.
An accompanying editorial by Paul S. Appelbaum, M.D., of the New York State Psychiatric Institute at Columbia University, points out that the proposed elements focus solely on the nature and risks of psychedelic treatment. “Although it would be difficult to quarrel with any of these suggestions, it is important to recognize that these elements are only part of a complete informed consent process.”
Applebaum pointed out that treatment questions pertaining to the optimal number of psychedelic episodes, the duration of response to psychedelic therapy, and the likelihood of response to psychedelic administration in the event of a relapse are all unknown. “At present, all that can—and should—be shared with patients is the profession’s uncertainty about these important issues,” he wrote.
Another source of uncertainty stems from the narrowly selected participant samples for most psychedelic research studies. Frequently excluded are people with personal or family histories of psychotic disorders, prior suicide attempts requiring hospitalization, manic episodes, or borderline personality disorders.
“Right now, there are essentially no data that can be enlisted to help such patients understand the unique risks, if any, that they may face,” Appelbaum wrote.
For related information, see the Psychiatric News article “Psychedelic Therapy Requires Enhanced Consent Discussions.”
(Image: Getty Images/iStock/mediaphotos)
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