This randomised controlled feasibility trial (n=40) will evaluate a 21-day digital intervention for psychedelic preparation (DIPP) using either a meditation-based or music-based programme, followed by a supervised 25 mg psilocybin session at University College London.
The study, conducted by University College London, aims to assess the feasibility, adherence, and acceptability of DIPP, a self-guided digital preparation programme designed to help individuals prepare for psychedelic experiences. Participants—healthy adults with minimal prior psychedelic and meditation experience—will be randomly assigned to one of two groups: a meditation-based intervention or a music-listening control. Both groups will engage in structured daily practices for 21 days before receiving a single 25 mg dose of psilocybin in a controlled setting.
Primary outcomes include recruitment efficiency, participant retention, and adherence to the intervention. Secondary measures will assess changes in psychedelic preparedness, quality of the psychedelic experience, and mental wellbeing. Follow-up assessments will take place in person at two weeks post-session and online at three, six, and nine months. Findings from this study will help refine digital preparation methods for psychedelic research and therapy.
Trial Details
This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences. Forty healthy volunteers will be randomly assigned to either a meditation-based intervention or a music-based control condition. Both groups will follow identical program structures, with the key distinction being their daily practice focus: meditation or music listening. Following the 21-day preparation period, participants will undergo a supervised 25 mg psilocybin session at University College London. Assessment visits include an in-person follow-up at 2 weeks post-session, followed by online assessments at 3, 6, and 9 months. The primary outcomes include operational feasibility (recruitment rates and participant retention) and intervention adherence (completion rates of DIPP program activities). Secondary outcomes include participant ratings of the platform's feasibility, acceptability, and usability, as well as changes in psychedelic preparedness, the quality of the psychedelic experience, and mental wellbeing over time.Trial Number NCT06815653
Sponsors & Collaborators
University College LondonIn October 2021, the Understanding Neuroplasticity Induced by Tryptamines (UNITY) Project was launched at University College London.