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RecruitingPhase 1

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

NCT06815653 · (DIPP-RCFT) · University College, London

Recruiting
Status
Accepting participants
Phase 1
Phase
40
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Recruitment efficiency

    Measured over Assessed at Visit 4 (2 weeks post-dose)

  • Study retention

    Measured over Assessed at Visit 4 (2 weeks post-dose)

  • DIPP intervention adherence

    Measured over Assessed at Visit 2 (1 day pre-dose)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: Aged 21-65 years. Limited psychedelic use (0-5 sessions involving a high/full dose, defined as producing noticeable psychoactive effects beyond microdosing; none in the past 6 months). Minimal meditation experience (≤10 sessions exceeding 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: 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 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).

Where

1 study site

FacilityCityRegionCountry
University College LondonLondonUnited Kingdom

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06815653 on ClinicalTrials.gov →

Last updated in the registry 2025-11-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits