Clinical TrialHealthy VolunteersPsilocybinPsilocybinWithdrawn

Optimizing Microdosing and Meditation (OMM)

Open-label, randomised feasibility trial (n=24) comparing psilocybin microdosing alone versus microdosing plus meditation in healthy adults; four supervised microdoses over two weeks.

Target Enrollment
24 participants
Study Type
Phase NA interventional
Design
Randomized

Detailed Description

This randomised parallel-group feasibility study (n=24) assesses recruitment, retention, acceptability, safety, and preliminary signals of effect for psilocybin microdosing with and without a group-based meditation programme in healthy adults in Oregon.

Participants receive four supervised 2-hour microdosing sessions across two weeks; one arm also receives morning online meditation practice Monday–Friday and integrates meditation into sessions with group discussion and psychoeducation.

Outcomes include feasibility targets (recruit ≥20/24, ≥80% retention), safety (AEs/SAEs), participant satisfaction, Oura Ring biometric measures (sleep, HRV), PROMIS-29, FFMQ, PSQI, 11-ASC, and qualitative interviews.

Study procedures operate within Oregon's Psilocybin Services framework; investigators study facilitation of services rather than directly providing psilocybin, and participants are informed of legal considerations.

Study Protocol

Preparation

1 sessions

Dosing

4 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Microdosing only

experimental

Psilocybin microdosing protocol over two weeks (no meditation).

Interventions

  • Psilocybin
    via Oral• two sessions per week for two weeks• 4 doses total

    Supervised psilocybin microdosing sessions per Oregon Psilocybin Services protocol; dose per service guidelines.

Microdosing + meditation

experimental

Same psilocybin microdosing protocol plus daily group-based meditation practice.

Interventions

  • Psilocybin
    via Oral• two sessions per week for two weeks• 4 doses total

    Supervised psilocybin microdosing sessions per Oregon Psilocybin Services protocol; dose per service guidelines.

  • Compound
    via Other• weekday online practice during 2-week intervention

    Morning online meditation instruction and practice Monday–Friday plus meditative practice during microdose sessions; group discussion and psychoeducation.

Participants

Ages
21 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age 21 or older (Oregon Psilocybin Services Act minimum age 21).
  • Able to attend all study events.
  • Able to read and speak fluent English.
  • No more than 100 hours of lifetime meditation experience.
  • No prior experience of microdosing of a psychedelic substance and no more than two macrodose experiences.

Exclusion Criteria

  • Exclusion Criteria:
  • A personal or family history of an immediate family member of schizophrenia, psychosis of any kind, mania, or hypomania.
  • Current prescription for lithium, antipsychotic, Phase II UGT substrate (e.g., diclofenac or probenecid), or unwillingness to taper medications judged to pose interaction risk.
  • Active suicidal ideation or history of suicide attempts. (Passive ideation such as "I wouldn't mind if I never woke up again" is permissible.)
  • Uncontrolled hypertension or heart disease.
  • Any form of personality disorder.
  • Current recreational drug use or any form of substance abuse in the previous six months.
  • Pregnancy, plans to become pregnant during the study period, or breastfeeding.
  • Active cancer treatment.
  • Any mental illness currently rated as severe (e.g., PHQ-9 >20, GAD-7 >14, or equivalents) or acute trauma-related symptoms.

Study Details

Locations

National University of Natural Medicine — Portland, Oregon, United States

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