Psilocybin Microdosing on Cognition, Mood and Quality of Life
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorYale University
About this trial
This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No history of psychedelic use OR
No use within 10 years, less than or equal to 7x in life OR
No use within 5 years, less than or equal to 3x in life
Able to read, speak, and understand English
Disqualifiers
Positive screen for recreational drugs or alcohol on test day will result in rescheduling the appointment
Current mood, developmental, or psychotic disorders (e.g., schizophrenia, affective disorders) per DSM-V
Current or past alcohol or substance use disorder per DSM-V
IQ <70 on the Weschler Abbreviated Scale of Intelligence
Trial design
Design model
Parallel
Treatments tested in this trial
Psliocybin
Drug2.0mg powdered psilocybin derived from Psilocybe cubensis mushrooms, in capsules, provided three times weekly for four weeks
Placebo
Drug0mg matching capsules, provided three times weekly for four weeks
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Psychedelic groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Complex Working Memory Span (CWMS) Task- fMRI measure
CWMS Task assesses immediate plus delayed recall and working memory by assessing working memory capacity by presenting a list of stimuli to be recalled while simultaneously performing a secondary task. This task uses a fully crossed design which includes both same-domain CWMS conditions (e.g. verbal storage combined with verbal processing) as well as cross-domain CWMS conditions (e.g., verbal storage combined with spatial processing). BOLD signal Infrontal lobe.
Time frame
From enrollment to end of treatment at 8 weeks.2
NEO-Five-Factor-Inventory (NEO-FFI)
The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree.
Time frame
From enrollment to end of treatment at 8 weeks.3
Beck Depression Inventory
This scale has a total of 21 items. Each item is scored from 0-3 points, and the total score ranges from 0-63 points. The higher the score, the higher the degree of depression.
Time frame
From enrollment to end of treatment at 8 weeks.4
Beck Anxiety Inventory
Beck Anxiety Inventory is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".
Time frame
From enrollment to end of treatment at 8 weeks.Secondary outcomes
1
Complex Working Memory Span task
Measures ability to juggle holding information (storage) and doing something with it (processing) at the same time. Percent accuracy will be reported.
Time frame
From enrollment to end of treatment at 8 weeks.2
fMRI
Mean BOLD signal
Time frame
From enrollment to end of treatment at 8 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Hartford HealthCare
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: