WithdrawnNot applicable

Optimizing Microdosing and Meditation

NCT06560658 · OMM · National University of Natural Medicine

Closed to entry

Status

Not accepting participants

Not applicable

Phase

—

Target enrolment

Study sites

1 US states

What it is testing

Summary

The goal of this clinical trial is to test the feasibility of combining meditation with psilocybin microdosing in healthy adults. The main questions it aims to answer are: 1. Recruitment and retention feasibility 2. Acceptability, Safety and Tolerability 3. Exploratory Measures: 3.1: Explore potential changes in sleep quality and duration, heart rate variability, and other biometric outcomes captured by the Oura Ring (3rd generation). 3.2: Explore potential changes in quality of life scores 3.3: Explore potential differences in altered states of consciousness across groups 3.4: Explore qualitative data collected during sessions and at follow-up to assess satisfaction and receive feedback about the intervention. Every participant will receive the psilocybin microdosing intervention, however, half of the participants will be randomly selected to receive the meditation intervention.

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 and Retention Feasibility
Measured over From time of approval to completion of the study, up to one year.
Acceptability
Measured over From time of approval to completion of the study, up to one year.
Safety and Tolerability
Measured over From time of approval to completion of the study, up to one year.

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

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Age 21 or older - Oregon Psilocybin Services Act sets the minimum eligible age of 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 two macrodose experiences. Exclusion Criteria: * A personal or family history of an immediate family member of schizophrenia, psychosis of any kind, mania, or hypomania. * A current prescription for lithium, antipsychotic, Phase II UGT substrate such as diclofenac or probenecid, or an unwillingness to taper off these or other medications that the study clinicians determine to be a risk for interactions. * Active suicidal ideations 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 breast feeding. * Active cancer treatment. * Any mental illness that could currently be rated as severe. This includes but is not limited to a PHQ-9 score above 20, GAD-7 score above 14, or their equivalents on comparable scales and acute trauma related symptoms.

Where

1 study site

Facility	City	Region	Country
National University of Natural Medicine	Portland	Oregon	United States

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.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06560658 on ClinicalTrials.gov →

Last updated in the registry 2025-06-05. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Recruiting in

Oregon7