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Mindfulness-assisted Psychedelic Therapy (MAPT)

Not yet recruitingRegisteredCTG

This randomised, open-label, parallel arm trial (n=40) will examine the potential synergy between psilocybin (25 mg, single dose) and 8 weeks of mindfulness training versus psilocybin alone in healthy adults.

Details

A pilot randomised open-label parallel trial in healthy adults (N=40) comparing a single oral 25 mg dose of psilocybin combined with an 8-week mindfulness training course versus psilocybin alone to evaluate feasibility and preliminary efficacy.

Assessments include questionnaires, computerized cognitive tests, and EEG at baseline and post-treatment, with brief follow-ups at 8 weeks and 1 year. Primary feasibility outcome is retention at 8 weeks; secondary outcomes include mood, inflammatory and neurotrophic markers, EEG measures, and safety (AEs).

Results will inform larger trials in clinical populations and future grant applications.

Topics:Healthy Volunteers

Registry

Registry linkNCT06233344