Optimizing Microdosing and Meditation
NCT Number: NCT06560658
Acronym: OMM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Meditation|Microdosing
Interventions: DRUG: Psilocybin|BEHAVIORAL: Meditation
Sponsor: National University of Natural Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2025-11-01
Locations: National University of Natural Medicine, Portland, Oregon, 97201, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Subjective Sleep quality and duration, Explore potential changes in sleep quality and duration via Pittsburgh Sleep Quality Index., 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, Explore potential changes in sleep quality and duration, heart rate variability, and other biometric outcomes captured by the Oura Ring (3rd generation)., Seven weeks, a one week wash-in period, two weeks during the primary intervention, and for four weeks post-intervention|Quality of life, Explore potential changes in quality of life scores assessed by PROMIS-29 (Patient Reported Outcomes Measurement Information System), which captures seven health domains (physical functioning, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbances)., At four time points in a seven week period|Altered states of consciousness, Explore potential differences in altered states of consciousness across groups using the 11-ASC (Eleven Dimensions of Altered States of Consciousness Rating Scale), At each of the four microdosing sessions during the two week intervention period|Qualitative data, Qualitative data will be collected during sessions and at follow-up including comments and feedback about the intervention., Collected at all study events, up to one year.