The Effects of Psilocybin on Shared Experience in Film Processing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Interpretive Phenomenological Analysis
研究概览
简要总结
The goal of this clinical trial is to learn whether our methods of detecting awareness in vegetative or minimally conscious patients (using neuroimaging) are sensitive to the effects of psilocybin (a psychedelic drug). One of these methods includes scanning people's brains while they watch a film. When different individuals watch a film, their brain's become synchronized with each other as they watch the plot unfold. Most importantly, if a seemingly unconscious patient also shows the same brain-synchronization, it means they might actually be conscious and aware.
To approach our goal, we will be carrying out this trial in healthy volunteers. This will help us better understand whether psilocybin may be a potential treatment for restoring awareness in these patients. The main questions it aims to answer are:
- Does psilocybin enhance or diminish brain synchrony during a film?
- Do changes in brain synchrony reflect differences in each individual's conscious experience?
Participants will be asked to:
- Attend two brain scanning sessions and watch a series of film clips, perform a brief mental imagery task, and listen to music - once under a placebo, and once under psilocybin.
- Play a series of games that assess their cognition (memory, reasoning, planning, etc.).
- Perform a series of visual illusions tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must:
- •Have access to an internet connection
- •Be in good general health
- •Be 19 years of age, or older
- •Be willing to follow the study protocol
排除标准
- •The following people will be excluded from the study. Those who:
- •Are unable to read English
- •Have high blood pressure
- •Are pregnant (determined by a urine pregnancy test at in-person screening)
- •Are not using effective methods of contraception with their partner(s) (e.g. oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, or barrier method)
- •Are taking chronic administration of tricyclic antidepressants and/or lithium
- •Are taking acute administration of serotonin reuptake inhibitors
- •Are currently using the antipsychotic medication haloperidol
- •Are currently using monoamine oxidase inhibitors
- •Have any current or past history of meeting the Diagnostic and Statistical Manual of Mental Illnesses (DSM-V) criteria for schizophrenia, bipolar I, bipolar II, or psychotic symptoms
- •Have any first or second-degree relatives with history of above disorders/symptoms
- •Have any other diagnosed and/or extreme psychiatric disorders, such as anxiety, depression, post-traumatic stress disorder (PTSD), addiction, obsessive-compulsive disorder (OCD), etc.
- •Have any history of suicidal behaviour or current/recent suicidal ideation (determined by the Columbia-Suicide Severity Rating Scale [C-SSRS] at in-person screening)
研究组 & 干预措施
Psilocybin First
Individuals in this arm will be given psilocybin for their first scanning session. For their second scanning session (at least two weeks later), they will receive the placebo.
干预措施: Psilocybin (Drug)
Psilocybin First
Individuals in this arm will be given psilocybin for their first scanning session. For their second scanning session (at least two weeks later), they will receive the placebo.
干预措施: Placebo (Other)
Placebo First
Individuals in this arm will be given the placebo for their first scanning session. For their second scanning session (at least two weeks later), they will receive psilocybin.
干预措施: Psilocybin (Drug)
Placebo First
Individuals in this arm will be given the placebo for their first scanning session. For their second scanning session (at least two weeks later), they will receive psilocybin.
干预措施: Placebo (Other)
结局指标
主要结局
Interpretive Phenomenological Analysis
时间窗: Through study completion, an average of 2 weeks. Analyzed following second scan (from interview data).
An analysis of the different themes that emerge (e.g. "feeling joy") when interviewing participants about their experience under the placebo or psilocybin. These themes will be correlated against ISC scores for each drug condition. Not scored on any scale; each theme's prevalence will be reported as a ratio and/or percentage.
Intersubject Correlation (ISC)
时间窗: Through study completion, an average of 2 weeks. ISC for each drug/task condition is computed and analyzed following second scan (from neuroimaging data).
The degree to which different participants' brain activity is correlated with one another (or synchronized) across the time-course of an in-scanner task (e.g. during a resting state, while watching film clips, while listening to music, etc.). Higher ISC scores indicate greater brain synchronization between individuals (minimum value=0, indicating no ISC/synchronization).
次要结局
- Reasoning Skills(Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).)
- Short-Term Memory(Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).)
- Verbal Reasoning(Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).)
研究者
Dr. Adrian Owen
Professor of Cognitive Neuroscience and Imaging
Western University, Canada