Study Protocol for "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study"

Area of Science:

• Psychiatry and Neuroscience
• Clinical Psychology
• Pharmacological Research

Background:

• Anorexia nervosa (AN) is a severe, life-threatening psychiatric disorder with limited treatment options.
• Novel therapeutic strategies are urgently needed for AN.
• Public Patient Involvement (PPI) is crucial for refining treatment protocols.

Purpose of the Study:

• To assess the feasibility of psilocybin-assisted therapy for anorexia nervosa.
• To investigate the brain mechanisms underlying psilocybin's effects in AN.
• To evaluate preliminary outcomes and participant experiences with psilocybin therapy for AN.

Main Methods:

• A pilot study involving 20 female participants (aged 21-65, BMI ≥15) with AN.
• Participants receive three oral doses of psilocybin (up to 25 mg) over 6 weeks within a therapeutic framework.
• Outcomes include psychopathology (Eating Disorder Examination), motivation for recovery, fMRI, and EEG measures.

Main Results:

• Public Patient Involvement (PPI) provided valuable insights into participant barriers and the concept of recovery.
• The study protocol is designed to assess feasibility, neurophysiological changes (fMRI, EEG), and preliminary efficacy.
• Detailed results on feasibility, brain mechanisms, and potential efficacy are pending study completion.

Conclusions:

• This pilot study will inform the design of a larger Randomized Control Trial (RCT) for psilocybin-assisted therapy in AN.
• Findings will illuminate the acceptability and potential of psilocybin as an adjunct treatment for anorexia nervosa.
• The study emphasizes the importance of integrating patient perspectives in clinical trial development.