Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults

ConditionAging
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUniversity of California, Berkeley

About this trial

Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults. After providing written informed consent, eligible participants, aged between 60 and 85, will be randomly assigned to receive a dose of psilocybin ranging from a microdose to a moderate-to-high dose. 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Psilocybin

    Drug

    Psilocybin 1-30 mg

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Psilocybin Level 1Experimental treatment 1 intervention
Group B: Psilocybin Level 2Experimental treatment 1 intervention
Group C: Psilocybin Level 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MRI measurements of brain structure

Diffusion-weighted MRI will be used to measure mean diffusivity in prefrontal cortex and hippocampus.

Time frame
Baseline, week 1, and week 4

Secondary outcomes

1

Amplitude and pattern of fMRI cortical responses

Functional magnetic resonance imaging (fMRI) responses to visual stimuli, diffusion-weighted MRI, and T1-weighted anatomical MRI will be used.

Time frame
Baseline, week 1, and week 4
2

Vagus nerve reactivity

Change from baseline visit on peripheral psychophysiology will be recorded using a validated task to assess vagus nerve activation during a baseline measurement compared to activation measured while viewing emotionally evocative video clips.

Time frame
Baseline, week 1, and week 4
3

Perceptual measurements

Perceptual measurements will be used to assess the effects of doses of psilocybin on participants' abilities to update visual prior expectations based on new information.

Time frame
Baseline, week 1, and week 4
4

Penn Conditional Exclusion Test (PCET)

A validated set-shifting measure of cognitive flexibility.

Time frame
Baseline, week 1, and week 4

Other outcomes

Sponsors and contacts

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