Feasibility study testing the protocol of single dose of psilocybin given to people who have had little improvements with brief psychological intervention

This open-label trial (n=30) will study the feasibility of administering a single dose of psilocybin (25mg) to adults with mild to moderate depression or anxiety who have shown limited improvement with brief psychological intervention.

The study will be conducted by the University of Otago and funded by the University and the Ashburn Clinic’s James Humes Bequest Fund. Participants will receive one 25 mg dose of psilocybin, followed by an 8-hour monitoring session reviewing prior therapeutic content. Acute measures will be taken 24 hours post-dosing, with further follow-ups at 6 and 12 weeks.

The primary outcomes include recruitment and retention rates and adherence to the study protocol. Secondary outcomes will measure changes in depression, anxiety, psychedelic experiences, and personality traits.

This feasibility study aims to inform a future blinded, placebo-controlled trial.

Trial Details

1. This study is an open label fixed sequence study design of participants with mood disturbances (mild – moderate depression/anxiety symptoms) who have had limited improvements from brief psychological intervention. Participants will be recruited after brief intervention with psychological services such as Student Health, Community Mental Health Teams, or private clinics. 2. Preparation session will consist of one two-hour session by team psychologist and psychology researcher that will occur in the week prior to administration of psilocybin which includes psychoeducation about the dosing and baseline measures. 3. Single dose of psilocybin administration (25mg) orally in the morning at the start of 8-hour long monitoring while reviewing content from participants' previous brief psychological input that they have learnt from their previous individual therapy sessions. The specific content is not controlled for aside from ensuring that they contain elements of Acceptance Commitment Therapy components - the range of content will be part of the descriptive analysis. 4. Acute measures will be taken approximately 24hrs after capsule administration and outcome measures taken at 6- and 12-week follow-up.

Trial Number ACTRN12624000816550p

Data attribution

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