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临床试验/NCT06560658
NCT06560658撤回不适用

Optimizing Microdosing and Meditation

National University of Natural Medicine1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
入组人数
24
试验地点
1
主要终点
Acceptability

研究概览

简要总结

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.

详细描述

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 Credibility/Expectancy 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 3.0 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 21 or older - Oregon Psilocybin Services Act sets the minimum eligible age of
  • •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.

排除标准

  • •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.

研究组 & 干预措施

Microdosing plus meditation

Experimental

干预措施: Meditation (Behavioral)

Microdosing only

Experimental

干预措施: Psilocybin (Drug)

Microdosing plus meditation

Experimental

干预措施: Psilocybin (Drug)

结局指标

主要结局

Acceptability

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

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

Recruitment and Retention Feasibility

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

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.

Safety and Tolerability

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Hicks

Principial Investigator

National University of Natural Medicine

研究点 (1)

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Optimizing Microdosing and Meditation | 临床试验