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

Summary & key facts

Researchers gave a single 25-milligram dose of synthetic psilocybin, plus psychological support, to 10 adult women with anorexia nervosa or partial remission. They were mainly checking safety and whether the treatment was tolerable and acceptable. No serious heart, vital sign, lab, or suicidal-risk problems were seen. Two people had low blood sugar without symptoms that got better within a day. The study was small and had no comparison group, so it cannot say whether psilocybin helps the eating disorder itself. Larger, controlled studies are needed to test if it works for symptoms.

Key facts:

• Ten adult women with anorexia nervosa or partial remission took part in the study.
• Each participant received a single 25-milligram dose of synthetic psilocybin together with psychological support.
• Researchers tracked heart readings, vital signs, lab tests, and suicidal thoughts to watch for safety problems.
• No clinically important changes were seen in heart readings, vital signs, or measures of suicidal thoughts after treatment.
• Two participants developed low blood sugar without symptoms after treatment; both returned to normal within 24 hours.
• All reported adverse events were mild and went away quickly, and most participants said the treatment felt acceptable to them.
• Because this was a small, open study without a comparison group, it cannot prove that psilocybin improves the core symptoms of anorexia nervosa.

Abstract

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 .

Topics

Body Image and Dysmorphia Studies Psychedelics and Drug Studies Sexuality, Behavior, and Technology

Categories

Clinical Psychology Psychology Social Sciences

Tags

Adverse effect Anorexia nervosa Asymptomatic Bulimia nervosa Eating disorders Hallucinogen Internal medicine Medicine Psilocybin Psychiatry Surgery Tolerability Vital signs

Substances

Psilocybin

Conditions & symptoms

Eating Disorder Poor appetite or overeating