Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367738
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults
Sponsor:
University of California Berkeley
Organization:
University of California Berkeley
Study Overview
Official Title:
Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will use cognitive exams perceptual tasks brain imaging peripheral psychophysiology and surveys to investigate the persisting effects of psilocybin on cognition predictive coding and affect in healthy older adults The investigators will measure changes in these measures by comparing baseline to one-week and one-month post-treatment Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose Dose response will be assessed Anatomical magnetic resonance imaging MRI and diffusion weighted imaging DWI will be used to assess changes in brain structure while functional magnetic resonance imaging fMRI will be used to quantify changes in functional brain activity The investigators will assess whether changes in these brain measures underlie observed changes in cognition predictive coding and affect
Detailed Description:
The investigators will use cognitive exams perceptual tasks brain imaging peripheral psychophysiology and surveys to investigate the persisting effects of psilocybin on cognition predictive coding and affect in healthy older adults The investigators will measure changes in these measures by comparing baseline to one-week and one-month post-treatment Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose Dose response will be assessed Anatomical magnetic resonance imaging MRI and diffusion weighted imaging DWI will be used to assess changes in brain structure while functional magnetic resonance imaging fMRI will be used to quantify changes in functional brain activity The investigators will assess whether changes in these brain measures underlie observed changes in cognition predictive coding and affect
The data from this study will provide a strong foundation for future studies to further investigate the effects of psychedelic-induced plasticity on cognition predictive coding and affect These experimental studies will be conducted in participants with no diagnosable mental health conditions but the resulting mechanistic insights may inform development of treatments that use psychedelics to help individuals shift from pathological patterns of thought emotion and behavior to more healthy and adaptive ones This information will be crucial for designing and optimizing mental health treatments using psychedelic agents Furthermore these studies may also reveal biomarkers that can then be used to predict the likelihood of a patients response to a particular type of therapeutic intervention
This project will include healthy older adults 60-85 years old allowing us to characterize the dose-dependent effects of psilocybin from the acute subjective experience to long-term persisting effects in old age Studying the effects of psilocybin in old age may inform the development of treatments that use psychedelics to improve cognition and affect in older adults by promoting brain changes that oppose the effects of synaptic dysfunction in aging and neurodegeneration in Alzheimers disease
The data from this study will provide a strong foundation for future studies to further investigate the effects of psychedelic-induced plasticity on cognition predictive coding and affect These experimental studies will be conducted in participants with no diagnosable mental health conditions but the resulting mechanistic insights may inform development of treatments that use psychedelics to help individuals shift from pathological patterns of thought emotion and behavior to more healthy and adaptive ones This information will be crucial for designing and optimizing mental health treatments using psychedelic agents Furthermore these studies may also reveal biomarkers that can then be used to predict the likelihood of a patients response to a particular type of therapeutic intervention
This project will include healthy older adults 60-85 years old allowing us to characterize the dose-dependent effects of psilocybin from the acute subjective experience to long-term persisting effects in old age Studying the effects of psilocybin in old age may inform the development of treatments that use psychedelics to improve cognition and affect in older adults by promoting brain changes that oppose the effects of synaptic dysfunction in aging and neurodegeneration in Alzheimers disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None