Psychedelic Use in Psychiatry Requires Complex Informed Consent, Experts Say

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.”

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Psychiatrists Outline Ethical Considerations Related to Psychedelics

“As psychedelic therapies gain increasing prominence, it is vital that psychiatrists remain mindful of unique ethical and practical challenges surrounding their use in clinical settings,” wrote Gregory Barber, M.D., a psychiatrist in private practice in Bethesda, Md., and Charles Dike, M.D., M.P.H., chair of the APA Ethics Committee, in a review article appearing in Psychiatric Services in Advance. Dike is also an associate professor of psychiatry at Yale University School of Medicine.

Contemporary research on psychedelics for the treatment of mental illness is focused primarily on psilocybin, found in a type of mushroom, and MDMA, a synthetic amphetamine derivative in the subgroup of psychedelics called empathogens. Barber and Dike underscored several ethical issues that psychiatrists may face regarding psychedelic therapies in clinical practice:

• Research equipoise amid high enthusiasm for psychedelics: Psychedelic therapies are in a relatively early stage of research. Research equipoise requires that researchers and clinicians must not decide what is true before the science informs their decision.
• Informed consent: Distinctive features of psychedelic psychotherapies may require what some have called “enhanced consent.” The goal of “enhanced consent” is to ensure that patients have a thorough understanding of psychedelic therapies. “These principles of consent apply in current research settings but would also be relevant in general clinical practice if psychedelics were to be approved for broader use,” they wrote.
• Patient vulnerability: Psychedelic psychotherapy involves profound and acute changes in consciousness, and some unique risks and possible adverse effects, which place patients in a vulnerable position. “Psychedelics are not effective or desirable for everyone, and psychiatrists should attempt to identify patients who are particularly vulnerable to negative outcomes before suggesting that [they] undergo a psychedelic experience,” they wrote.
• Off-label use of psychedelics: “If psychedelics are approved for general psychiatric use, psychiatrists will likely encounter patients who seek psychedelic therapies,” they wrote. In that case, psychiatrists should be mindful that psychedelics should be prescribed only to treat diagnosable psychiatric disorders. Patients should be carefully screened for any underlying psychopathology. “If no clinical indication is found, psychiatrists should avoid prescribing psychedelics, just as they would any other medication.”
• Nonclinical uses of psychedelics: Psychiatrists may already be hearing from patients who are seeking their advice about the use of psychedelics outside clinical settings. Psychiatrists should be clear that although clinical trials are promising, these medications are still in the experimental stage. Such conversations may offer opportunities to educate patients on “the difference between psychedelic use in a clinical setting, where clear protocols are in place to ensure patient safety, and in a naturalistic setting [for example, for recreational use], where efficacy and safety are less assured,” they wrote.
• Equity and access: As research and clinical applications of psychedelics expand, efforts should be made to ensure that these interventions can be accessed by anyone who may benefit from them and are not reserved for a select few.

“As psychedelics become more prominent in psychiatry, psychiatrists should continue to emphasize their safe, effective, and ethical use,” Barber and Dike wrote.

For related information, see the Psychiatric News article “Psychedelics Legislation Gains Momentum.”

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