Psilocybin therapy safe and may help people with anorexia nervosa

Psilocybin is a psychedelic molecule whose mechanism of action is suggested to be mediated by serotonin 2A (5-HT2A) and is the main psychoactive compound in the mushrooms' Psilocybe genus.

The findings from the phase 1, open-label feasibility study, published in Nature Medicine are promising given physiological dangers and problems with treatment engagement.

Anorexia nervosa is a fatal illness with no proven treatments to reverse core symptoms and no medications are approved by the US Food and Drug Administration (US FDA). Therefore, there is an urgent need for novel treatments to improve clinical outcomes.

Previous observational and naturalistic studies investigating the value of psilocybin and other psychedelic drugs in people with eating disorders (EDs) have reported on emerging themes, such as increased intellectual and affective awareness, reduction in ED symptoms, emotional processing, positive mood changes, and increases in self-acceptance.

Considering that no modern publication has reported data on the safety, efficacy, and tolerability of psilocybin for AN patients Stephanie Knatz Peck, University of California, San Diego, San Diego, CA, USA, and colleagues conducted the first modern trial to report these parameters of a single 25-mg dose of psilocybin in conjunction with psychological support.

"To our knowledge, this is the first data report on the effects of psilocybin therapy in anorexia nervosa in a clinical research trial," the researchers wrote.

The study, conducted at an academic clinical research institute, included ten adult female patients (mean BMI 19.7 kg m−2) who met the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for AN or (partial remission).

Participants were given a single 25-mg dose of synthetic psilocybin in addition to psychological support. The researchers primarily assessed the feasibility, safety, and tolerability at post-treatment by occurrences and incidences of adverse events (AEs) and clinically significant changes in laboratory tests, electrocardiogram (ECG), suicidality, and vital signs.

The authors reported the following findings:

• No clinically significant changes were observed in ECG, vital signs or suicidality. Two participants developed asymptomatic hypoglycemia at post-treatment, which resolved within 24 h.
• No other clinically significant changes were observed in laboratory values.
• All adverse events were mild and transient.
• Participants’ qualitative perceptions suggest that the treatment was acceptable for most participants.

"Findings from this open-label, single-arm study indicate that psilocybin therapy is safe and tolerable in patients with AN; however, there is a need for adequately powered, randomized controlled trials to draw any conclusions," Dr. Knatz Peck and the team concluded.

Reference:

Peck, S. K., Shao, S., Gruen, T., Yang, K., Babakanian, A., Trim, J., Finn, D. M., & Kaye, W. H. (2023). Psilocybin therapy for females with anorexia nervosa: A phase 1, open-label feasibility study. Nature Medicine, 1-7. https://doi.org/10.1038/s41591-023-02455-9