Clinical TrialHealthy VolunteersPsilocybinPsilocybinRecruiting

Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs (DIPP-RCFT)

Randomised controlled feasibility trial (n=40) comparing a 21-day meditation-based DIPP versus a music-based DIPP control, each followed by a supervised 25 mg psilocybin session at University College London.

Target Enrollment
40 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

This feasibility randomised trial assigns 40 healthy volunteers 1:1 to either a 21-day digital meditation programme or an active music-listening control. The aim is to evaluate operational feasibility, adherence, and preliminary signals of intervention acceptability.

Following the preparation period, all participants receive a single supervised oral dose of 25 mg psilocybin. Assessments include platform usability and feasibility measures, psychedelic preparedness, acute experience quality, and mental wellbeing at 2 weeks, 3, 6 and 9 months.

Primary outcomes are recruitment/retention and DIPP adherence; secondary outcomes are descriptive implementation metrics and preliminary efficacy measures to inform future trials.

Study Protocol

Preparation

21 sessions

Dosing

1 sessions
360 min each

Integration

sessions

Study Arms & Interventions

Meditation

experimental

21-day digital meditation-based preparation followed by a supervised 25 mg oral psilocybin session.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg synthetic psilocybin in HPMC capsule (GMP).

Music Listening

active comparator

21-day music-listening control programme followed by a supervised 25 mg oral psilocybin session.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg synthetic psilocybin in HPMC capsule (GMP).

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Aged 21-65 years. Limited psychedelic use (0-5 sessions involving a high/full dose; none in the past 6 months).
  • Minimal meditation experience (≤10 sessions >30 minutes; no retreats or regular practice).
  • Native English speaking. Normal or corrected-to-normal colour vision. Able and willing to provide informed consent. Able to engage with all study requirements, including in-person and remote sessions.
  • UK resident registered with a primary care practice. Agree to allow research team contact with primary/secondary care teams if needed.
  • Access to mobile smartphone.

Exclusion Criteria

  • Exclusion Criteria:
  • Current or past psychiatric diagnosis (e.g., depression, anxiety) unless in clear remission for at least 5 years and assessed as low-risk.
  • Current or past psychotic or bipolar disorder diagnosis. First degree relative with psychotic or bipolar disorder diagnosis. Current or past suicidal behaviours, including attempts, planning, or intention.
  • Medically significant physical health conditions (e.g., cardiovascular disease, uncontrolled hypertension, epilepsy, migraines, focal scalp sensitivity, or any condition posing a safety risk).
  • Use of medications interacting with psilocybin (e.g., antipsychotics, SSRIs, SNRIs, TCAs, mood stabilisers).
  • Psychoactive drug use within 30 days (except nicotine or caffeine). Pregnancy, planning pregnancy, or breastfeeding. Participation in a drug trial within 6 months. MRI contraindications (e.g., metal implants, pacemakers, severe claustrophobia).

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment40 participants
  • Timeline
    Start: 2025-03-01
    End: 2026-12-01
  • Compounds
    PsilocybinPsilocybin
  • Topic
    Healthy Volunteers

Locations

University College London — London, United Kingdom

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