Optimizing Microdosing and Meditation

Withdrawn before enrolling · Not applicable

Conditions studied: Meditation, Microdosing

In brief

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.

Key facts

Study ID

NCT06560658

Run by

National University of Natural Medicine

People needed

0

Starts

2024-10-01

Expected to finish

2025-11-01

Last updated by the study team

2025-06-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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