Optimizing Microdosing and Meditation

NCT06560658 | Withdrawn

• 1 other identifier: OMM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 1.Recruitment and retention feasibility
2. 2.Acceptability, Safety and Tolerability
3. 3.Exploratory Measures:

Conditions

Meditation; Microdosing

Keywords

psilocybin; microdosing; meditation

Outcome Measures

Primary Outcomes (3)

• Recruitment and Retention Feasibility

  Determine the recruitment rate (number of participants enrolled compared to those approached). Evaluate the participant retention rate throughout the study, including psilocybin sessions and follow-up assessments.

  From time of approval to completion of the study, up to one year.

• Acceptability

  Assess participant satisfaction with the group psilocybin-assisted therapy format through qualitative interviews and survey questions.

  From time of approval to completion of the study, up to one year.

• Safety and Tolerability

  Monitor the incidence and severity of adverse events associated with psilocybin administration in a group setting.

  From time of approval to completion of the study, up to one year.

Other Outcomes (5)

• Subjective Sleep quality and duration

  Seven weeks, a one week wash-in period, two weeks during the primary intervention, and for four weeks post-intervention

• Objective Sleep quality and duration

  Seven weeks, a one week wash-in period, two weeks during the primary intervention, and for four weeks post-intervention

• Quality of life

  At four time points in a seven week period

Study Arms (2)

Microdosing only

EXPERIMENTAL

Drug: Psilocybin

Microdosing plus meditation

EXPERIMENTAL

Drug: Psilocybin; Behavioral: Meditation

Interventions

Psilocybin DRUG

Participants will receive four 2-hour sessions of supervised microdosing of psilocybin in a two week period.

Also known as: psilocybin microdosing

Microdosing only; Microdosing plus meditation

Meditation BEHAVIORAL

Participants will receive four 2-hour sessions of supervised microdosing of psilocybin in a two week period. In addition to meditating during their sessions, participants will also meet online five days a week for meditation instruction and practice.

Microdosing plus meditation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

Location

MeSH Terms

Interventions

Psilocybin; Meditation

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Matthew Hicks, ND, MS

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)