Clinical trial NCT06529939: The Effects of Psilocybin on Shared Experience in Film Processing
Official title: The Effects of Psilocybin on Shared Experience in Film Processing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disorders of Consciousness
Psychedelic Experiences
Keywords: Psilocybin
Functional Magnetic Resonance Imaging (fMRI)
Cognition
Disorders of Consciousness
Film Processing
Healthy Volunteers
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn whether certain 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 peoples\&#39; brains while they watch a film. When different individuals watch a film, their brains 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 this goal, the investigators will be carrying out this trial in healthy volunteers. This will help 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\&#39;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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

Primary outcomes:
measure: Intersubject Correlation (ISC)
timeFrame: Through study completion, an average of 2 weeks. ISC for each drug/task condition is computed and analyzed following second scan (from neuroimaging data).
measure: Interpretive Phenomenological Analysis
timeFrame: Through study completion, an average of 2 weeks. Analyzed following second scan (from interview data).
Secondary outcomes:
measure: Short-Term Memory
timeFrame: Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).
measure: Verbal Reasoning
timeFrame: Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).
measure: Reasoning Skills
timeFrame: Through study completion, an average of 2 weeks. Analyzed following second scan (from Creyos cognitive scores).
Other outcomes:
Locations:
Study officials:
References:
citation: Scott G, Carhart-Harris RL. Psychedelics as a treatment for disorders of consciousness. Neurosci Conscious. 2019 Apr 21;2019(1):niz003. doi: 10.1093/nc/niz003. eCollection 2019.
citation: Schartner MM, Carhart-Harris RL, Barrett AB, Seth AK, Muthukumaraswamy SD. Increased spontaneous MEG signal diversity for psychoactive doses of ketamine, LSD and psilocybin. Sci Rep. 2017 Apr 19;7:46421. doi: 10.1038/srep46421.
citation: Hasson U, Landesman O, Knappmeyer B, Vallines I, Rubin N, Heeger DJ. Neurocinematics: The neuroscience of film. Projections. 2008;2(1):1-26.
citation: Naci L, Cusack R, Anello M, Owen AM. A common neural code for similar conscious experiences in different individuals. Proc Natl Acad Sci U S A. 2014 Sep 30;111(39):14277-82. doi: 10.1073/pnas.1407007111. Epub 2014 Sep 15.
citation: Naci L, Sinai L, Owen AM. Detecting and interpreting conscious experiences in behaviorally non-responsive patients. Neuroimage. 2017 Jan 15;145(Pt B):304-313. doi: 10.1016/j.neuroimage.2015.11.059. Epub 2015 Dec 8.