This single-arm, open-label trial (n=15) aims to assess the feasibility, acceptability, and safety of Psilocybin-Assisted Supportive Psychotherapy in treating prolonged grief disorder in bereaved cancer carers.
Conducted by the QIMR Berghofer Medical Research Institute in Australia, the study involves three psychotherapy sessions before a psilocybin dosing session and four post-experience integration sessions.
Participants will be closely monitored by trial psychologists and nurses. Rigorous screening will be conducted to ensure eligibility, and baseline and follow-up assessments will measure prolonged grief symptoms. Feasibility, acceptability, and safety will be evaluated through recruitment and retention rates, fidelity to assessments, and adverse event monitoring.
The trial aims to provide an initial impression of efficacy through qualitative analysis of participants’ experiences and changes in grief scores.
The intervention, supported by Woke Pharmaceuticals, involves administering 25 mg of psilocybin orally. Recruitment started on 13th November 2023, with an anticipated completion date of 22nd April 2024.
Trial Details
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Sponsors & Collaborators
Woke PharmaceuticalsWoke Pharmaceuticals is an Australian biotech company developing novel psychedelic compounds.