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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Childhood Abuse May Impact Development of Close Social Bonds as Adults

Adults who experienced significant abuse or neglect during childhood may exhibit a preference for more “personal space” and discomfort with some types of social touching, reports a study in AJP in Advance.

“This sensory dysregulation may explain why individuals with severe childhood maltreatment often suffer from difficulties in establishing and maintaining close social bonds later in life,” wrote Ayline Maier, M.Sc., of the University of Bonn in Germany and colleagues. “Our results may have important implications for the understanding and effective treatment of childhood maltreatment and associated psychopathology.”

Maier and colleagues enrolled 92 adults who were not taking psychotropic medications and who had varying exposure to childhood maltreatment as assessed by the 25-item Childhood Trauma Questionnaire, which measures emotional, physical, and sexual abuse as well as emotional and physical neglect. The sample was divided into three groups: 33 adults with low childhood maltreatment (average score of 26), 30 adults with moderate maltreatment (average score of 36), and 29 with high maltreatment (average score of 63).

All participants completed an interpersonal distance assessment, whereby they slowly moved toward an unfamiliar person until they felt uncomfortable, and a social touch assessment, in which they received either slow or fast hand movements on their shins while undergoing MRI testing.

The data showed that adults in the high-maltreatment group reported a significantly greater amount of ideal personal space between them and another person than those with low maltreatment (about 35.5 inches versus 31.5 inches apart). The adults with high childhood maltreatment also reported more discomfort with fast shin touches compared with adults with low maltreatment. This increased discomfort correlated with greater activity in the sensory regions of the frontal cortex, suggesting that the brain is preparing a flight-or-fight decision in response to the touch, Maier and colleagues wrote.

Cognitive-behavioral therapy approaches do not directly address sensory-related discomfort that many of these individuals experience, the researchers noted. However, previous research has shown the effectiveness of massage for patients who have been sexually abused or have PTSD. The researchers concluded that the use of body-based interventions “could help individuals with a history of childhood maltreatment to facilitate their participation in social interactions by learning to tolerate and enjoy the comforts of social touch in a safe environment.”

To read more about this topic, see the Psychiatric News article “Prospective Study Delves Deeper Into Mental Health Effects of Childhood Trauma.”

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