Toward Embodied Healing: Feasibility of a Psilocybin-Assisted Psychotherapy for Partially Recovered Anorexia Nervosa and Persistent Body Image Disturbance. A Manualised, Three-Dose, Open-Label Case Study

This open-label interventional trial (n=10) assesses the feasibility, safety, and preliminary efficacy of psilocybin-assisted therapy (1x 5mg, 2x 25mg) for body image disturbance (BID) in women with a history of anorexia nervosa.

Led by Swinburne University of Technology, Australia, the study involves three doses of psilocybin alongside 14 therapy sessions. Participants are required to have a BMI of at least 18.5 and persistent BID, with prior evidence-based treatment for their eating disorder. Each participant must nominate a support person to participate in the study.

The trial aims to recruit its first participant in April 2024, with an anticipated completion date in November 2025.

Topic Eating Disorders Anxiety Safety
Compound Psilocybin
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 April 2024
End date 30 November 2025
Phase Phase I Phase II
Design Open
Type Interventional
Generation First
Participants 10
Sex Female
Age 21- 99
Therapy Yes

Trial Details

This project is designed to assess the safety, feasibility and preliminary efficacy of psilocybin-assisted therapy (PAP) for body image disturbance (BID) in individuals with a history of anorexia nervosa. Participants will receive three doses of psilocybin alongside 14 sessions of therapy. Female participants will be required to have a history of anorexia nervosa. These participants will be medically stable and in a range of weight restoration, with a minimum body mass index (BMI) of 18.5 and will have persistent BID. Participants will also be required to have had a minimum of one episode of evidence-based care for their eating disorder. Participants will be expected to nominate an adult caregiver (“Support”, e.g. parent, partner, sibling, etc.) to participate in the study. Participant Supports will be required to commit to 3 non-dosing sessions.

NCT Number ACTRN12624000343505p

Sponsors & Collaborators

Swinburne University of Technology
Swinburne University of Technology, located in Melbourne, Australia, is known for its focus on innovation, industry engagement, and social inclusion.

Data attribution

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