Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560658
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Optimizing Microdosing and Meditation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Microdosing and Meditation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMM
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 Recruitment and retention feasibility
2 Acceptability Safety and Tolerability
3 Exploratory Measures
31 Explore potential changes in sleep quality and duration heart rate variability and other biometric outcomes captured by the Oura Ring 3rd generation
32 Explore potential changes in quality of life scores 33 Explore potential differences in altered states of consciousness across groups 34 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
1 Recruitment and retention feasibility
2 Acceptability Safety and Tolerability
3 Exploratory Measures
31 Explore potential changes in sleep quality and duration heart rate variability and other biometric outcomes captured by the Oura Ring 3rd generation
32 Explore potential changes in quality of life scores 33 Explore potential differences in altered states of consciousness across groups 34 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
Detailed Description:
Research has shown that both meditation and high doses of psilocybin can produce enhanced feelings of well-being that persist When combined the synergistic effects might be more than the sum of the parts when treating mental health challenges like depression The results for microdosing on the other hand are mixed and there have yet to be studies on the synergy between microdosing and meditation
If the synergy between microdoses of psilocybin and meditation is significant this suggests the possibility of a safe effective and low-cost intervention involving group-based meditation training and practice combined with a psilocybin microdosing protocol The Oregon Psilocybin Services program provides a unique opportunity to test this possibility in the context of services now legally available to clients allowing researchers to assess the safety and efficacy in a real-life context
Project aims and methods This study aims to test the feasibility of the model by assessing recruitment retention acceptability safety and preliminary efficacy of the intervention In addition to an appropriate medical screening and intake we will collect questionnaire data using the CredibilityExpectancy Questionnaire CEQ PROMIS-29 Five Facet of Mindfulness Questionnaire FFMQ Pittsburgh Sleep Quality Index PSQI Altered States of Consciousness 11-ASC rating scale and a survey and structured interview During a one week wash-in period the intervention period and for one month after the intervention Oura rings will be used to collect over 20 biometric data points including sleep quality respiration rate heart rate variability and more
Participants will consist of adults in Oregon that will be individually screened by a study investigator and then randomized into two arms One arm will receive microdosing only consisting of one group preparation session and two microdosing sessions per week for two weeks The other arm will receive the same microdosing protocol with the addition of morning online meditation practice Monday through Friday for both weeks and will utilize meditation practices during their microdose sessions The meditation sessions will include opportunities for the group to discuss their meditation experiences and a psychoeducational component to further improve outcomes This content will provide participants with a better understanding of the ruminations that interrupt their focus while meditating and encourage greater distance from and less distress concerning those thoughts
Expected outcomes The authors hypothesize that the model will be feasible if we are able to recruit at least 20 out of 24 expected participants have an 80 retention rate of participants during the two week intervention period participants on average rate their satisfaction of the intervention as 30 or higher on a 5-point scale there are no more than ten adverse events or more than one serious adverse event and data from exploratory measures indicate that further investigation is warranted
Despite the US Food and Drug Administration FDA granting Breakthrough Therapy status to psilocybin for the treatment of depression56 it remains on the Drug Enforcement Agencys DEA Schedule I list of controlled substances alongside heroin and cocaine While the DEA and the FDA have become increasingly more willing to grant waivers for research into psychedelic drugs the proposed study does not require such a waiver to comply with the law This is due to the unique construction of Oregons Psilocybin Services Act Chapter 475A of Oregon Statutes The state law creates a program wherein licensed growers inspected by licensed laboratories can distribute psilocybin mushrooms to licensed service centers It is only within the approved boundaries of these service centers and while supervised by a licensed facilitator that the mushrooms can be consumed by clients who must stay on site for a designated amount of time that depends on the dose
According to Oregon Health Authority Administrative rule 333-333-5130 facilitators of psilocybin service are prohibited from 1 practicing any other scope of practice they may have eg naturopathic medicine while facilitating and 2 handling selling or transferring psilocybin at any time Thus while it is technically true that growers services centers and clients are liable for trafficking and possession of a Schedule I substance the federal government has adopted a policy of allowing state programs such as this in a manner similar to their policy on cannabis Complying with Oregon law means that study investigators are not administering or providing psilocybin but instead are studying the facilitation of the services At the request of the Institutional Review Board IRB of the National University of Natural Medicine NUNM for a similar study this rationale was confirmed via direct communication with the regional DEA office who agreed with this interpretation of both federal and state law Participants are given clear information on their liability in order to provide consent
If the synergy between microdoses of psilocybin and meditation is significant this suggests the possibility of a safe effective and low-cost intervention involving group-based meditation training and practice combined with a psilocybin microdosing protocol The Oregon Psilocybin Services program provides a unique opportunity to test this possibility in the context of services now legally available to clients allowing researchers to assess the safety and efficacy in a real-life context
Project aims and methods This study aims to test the feasibility of the model by assessing recruitment retention acceptability safety and preliminary efficacy of the intervention In addition to an appropriate medical screening and intake we will collect questionnaire data using the CredibilityExpectancy Questionnaire CEQ PROMIS-29 Five Facet of Mindfulness Questionnaire FFMQ Pittsburgh Sleep Quality Index PSQI Altered States of Consciousness 11-ASC rating scale and a survey and structured interview During a one week wash-in period the intervention period and for one month after the intervention Oura rings will be used to collect over 20 biometric data points including sleep quality respiration rate heart rate variability and more
Participants will consist of adults in Oregon that will be individually screened by a study investigator and then randomized into two arms One arm will receive microdosing only consisting of one group preparation session and two microdosing sessions per week for two weeks The other arm will receive the same microdosing protocol with the addition of morning online meditation practice Monday through Friday for both weeks and will utilize meditation practices during their microdose sessions The meditation sessions will include opportunities for the group to discuss their meditation experiences and a psychoeducational component to further improve outcomes This content will provide participants with a better understanding of the ruminations that interrupt their focus while meditating and encourage greater distance from and less distress concerning those thoughts
Expected outcomes The authors hypothesize that the model will be feasible if we are able to recruit at least 20 out of 24 expected participants have an 80 retention rate of participants during the two week intervention period participants on average rate their satisfaction of the intervention as 30 or higher on a 5-point scale there are no more than ten adverse events or more than one serious adverse event and data from exploratory measures indicate that further investigation is warranted
Despite the US Food and Drug Administration FDA granting Breakthrough Therapy status to psilocybin for the treatment of depression56 it remains on the Drug Enforcement Agencys DEA Schedule I list of controlled substances alongside heroin and cocaine While the DEA and the FDA have become increasingly more willing to grant waivers for research into psychedelic drugs the proposed study does not require such a waiver to comply with the law This is due to the unique construction of Oregons Psilocybin Services Act Chapter 475A of Oregon Statutes The state law creates a program wherein licensed growers inspected by licensed laboratories can distribute psilocybin mushrooms to licensed service centers It is only within the approved boundaries of these service centers and while supervised by a licensed facilitator that the mushrooms can be consumed by clients who must stay on site for a designated amount of time that depends on the dose
According to Oregon Health Authority Administrative rule 333-333-5130 facilitators of psilocybin service are prohibited from 1 practicing any other scope of practice they may have eg naturopathic medicine while facilitating and 2 handling selling or transferring psilocybin at any time Thus while it is technically true that growers services centers and clients are liable for trafficking and possession of a Schedule I substance the federal government has adopted a policy of allowing state programs such as this in a manner similar to their policy on cannabis Complying with Oregon law means that study investigators are not administering or providing psilocybin but instead are studying the facilitation of the services At the request of the Institutional Review Board IRB of the National University of Natural Medicine NUNM for a similar study this rationale was confirmed via direct communication with the regional DEA office who agreed with this interpretation of both federal and state law Participants are given clear information on their liability in order to provide consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None