Psilocybin Therapy for Females With Anorexia Nervosa: A Phase 1, Open-Label Feasibility Study
FOCUS The Journal of Lifelong Learning in Psychiatry – July 01, 2024
Source: OpenAlex
Summary
A single 25-mg dose of synthetic psilocybin appears safe and tolerable for women with anorexia nervosa, a deadly illness lacking approved medicine. In an open-label study, 10 adult female participants, with a mean body mass index of 19.7 kg m<sup>-2</sup>, received this chemical synthesis and alkaloids compound. No serious adverse events occurred; only two participants experienced temporary hypoglycemia. This finding offers hope for psychiatry, especially since the Food and Drug Administration has no approved treatments for anorexia. Future Psychedelics and Drug Studies, considering sexuality, behavior, and technology, could further explore this medicine.
Abstract
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. ClinicalTrials.gov identifier NCT04661514. Appeared originally in Nat Med 2023; 29:1947-1953.