This open-label feasibility study (n=10) examines the effects of a single dose of psilocybin (25mg; COMP360) on adult female participants diagnosed with Anorexia Nervosa (AN) or pAN (partial remission). Results show that the treatment was safe, tolerable, and acceptable, with no significant changes in ECG, vital signs, or suicidality. However, two participants developed asymptomatic hypoglycemia (low blood sugar), which resolved within 24 hours. No significant changes in BMI were found.

Abstract of Psilocybin therapy for females with anorexia nervosa

“Anorexia nervosa (AN) is a deadly illness with no proven treatments to reverse core symptoms and no medications approved by the US Food and Drug Administration. Novel treatments are urgently needed to improve clinical outcomes. In this open-label feasibility study, 10 adult female participants (mean body mass index 19.7 kg m⁻²; s.d. 3.7) who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for AN or pAN (partial remission) were recruited to a study conducted at an academic clinical research institute. Participants received a single 25-mg dose of synthetic psilocybin in conjunction with psychological support. The primary aim was to assess safety, tolerability and feasibility at post-treatment by incidences and occurrences of adverse events (AEs) and clinically significant changes in electrocardiogram (ECG), laboratory tests, vital signs and suicidality. 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 AEs were mild and transient in nature. Participants’ qualitative perceptions suggest that the treatment was acceptable for most participants. Results suggest that psilocybin therapy is safe, tolerable and acceptable for female AN, which is a promising finding given physiological dangers and problems with treatment engagement.”

Authors: Stephanie Knatz Peck, Samantha Shao, Tessa Gruen, Kevin Yang, Alexandra Babakanian, Julie Trim, Daphna M. Finn & Walter H. Kaye

Summary of Psilocybin therapy for females with anorexia nervosa

Psilocybin therapy, a psychedelic molecule whose mechanism of action is thought to be mediated by serotonin 2A (5-HT2A), may improve symptoms of anorexia nervosa (AN). However, the role of 5-HT dysfunction in AN and related affective states associated with restriction remains poorly understood with mixed findings.

Psilocybin may directly modulate the serotonergic system, indirectly modulate dopaminergic and glutamatergic systems and gene expression, and improve mental health status by increasing emotional and brain network plasticity. Psilocybin therapy may hold promise for other treatment-resistant mental illnesses.

AN is characterized by excessive and undue preoccupation, fear and distress surrounding food, weight, shape and eating. Psilocybin therapy has been shown to improve anxiety and cognitive flexibility, which may help to disrupt cardinal symptoms of AN, such as eating disorder-related preoccupations, rigid thinking styles and entrenched behavioral patterns.

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Find this paper

Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study

https://doi.org/10.1038/s41591-023-02455-9

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Cite this paper (APA)

Peck, S.K., Shao, S., Gruen, T. et al. Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. Nat Med (2023). https://doi.org/10.1038/s41591-023-02455-9

Study details

Compounds studied
Psilocybin

Topics studied
Eating Disorders

Study characteristics
Original Open-Label

Participants
10 Humans

Institutes

Institutes associated with this publication

University of California San Diego
The Psychedelics and Health Research Initiative (PHRI) at UC San Diego conducts novel basic and clinical research on the use of psychedelics.

Compound Details

The psychedelics given at which dose and how many times

Psilocybin 25 mg | 1x

Linked Clinical Trial

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.