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Completion

Pilot study of administration of psilocybin in healthy volunteers within a marae

Not yet recruitingRegisteredANZCTR

This interventional trial (n=12) will assess the feasibility and acceptability of administering a single 25 mg oral dose of psilocybin to healthy Māori volunteers in a marae setting under clinical supervision (open-label, single-group, Phase I).

Details

Single-group, open-label Phase I feasibility study enrolling 12 healthy Māori volunteers to receive a single 25 mg oral capsule of psilocybin in a marae setting with clinical and cultural supervision.

Primary outcomes are feasibility and acceptability; safety assessed via adverse events, vitals and screening for suicidality (C-SSRS). Key exclusions include personal or first-degree family history of psychosis, recent psychedelic use, substance dependence, and BMI outside 18–35.

Topics:Healthy Volunteers

Registry

Registry linkACTRN12624000869572