Effects of Psilocybin on Shared Experience
NCT Number: NCT06529939
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Disorders of Consciousness|Psychedelic Experiences
Interventions: DRUG: Psilocybin|DRUG: Placebo
Sponsor: Western University, Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-09

Summary:
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.

Primary Outcome Measures: Intersubject Correlation (ISC), 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)., Through study completion, an average of 2 weeks. ISC for each drug/task condition is computed and analyzed following second scan (from neuroimaging data).|Interpretive Phenomenological Analysis, 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., Through study completion, an average of 2 weeks. Analyzed following second scan (from interview data).
Secondary Outcome Measures: Short-Term Memory, An assessment of the short-term memory abilities of each participant. These scores are computed by the Creyos online cognitive testing platform, from each participants' performance on the suite of web-based games (which assess memory, spatial/verbal reasoning, planning, and concentration). Data will likely be reported as a normalized score with no min/max value (higher scores will indicate a better outcome)., Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).|Verbal Reasoning, An assessment of the verbal reasoning abilities of each participant. These scores are computed by the Creyos online cognitive testing platform, from each participants' performance on the suite of web-based games (which assess memory, spatial/verbal reasoning, planning, and concentration). Data will likely be reported as a normalized score with no min/max value (higher scores will indicate a better outcome)., Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).|Reasoning Skills, An assessment of the logical reasoning skills of each participant. These scores are computed by the Creyos online cognitive testing platform, from each participants' performance on the suite of web-based games (which assess memory, spatial/verbal reasoning, planning, and concentration). Data will likely be reported as a normalized score with no min/max value (higher scores will indicate a better outcome)., Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).