Health TrialsbyHealthPanel

Subjective Experience Following Psilocybin

ConditionInvestigating the Importance of the Subjective Psychedelic Experience
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Calgary

About this trial

The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals of all sexes, gender identities, and ethnicities

Ages 18 to 65 years of age at the time of screening

Ability to read/write in English

Agree not to consume psychoactive drugs 24 hours before dosing sessions or consume psychedelics during duration of study participation

Disqualifiers

Any notable abnormality on electrocardiogram or routine medical blood or urinalysis laboratory tests

Current psychiatric diagnoses, such as: major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, moderate to severe substance use disorders, eating disorders, personality disorders, post-traumatic stress disorder

Lifetime or current psychiatric diagnoses of: psychosis, schizophrenia, bipolar disorder

Family history: a first- or second degree relative with a history of schizophrenia or other psychotic disorders, bipolar I or II

Trial design

Design model

Factorial

Treatments tested in this trial

  • Psilocybin high-dose

    Drug

    The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the high-dose

  • Psilocybin low-dose

    Drug

    The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the low-dose.

  • Risperidone 1 MG

    Drug

    risperidone 1mg capsules

  • Placebo

    Drug

    inactive placebo

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: High-dose psilocybin + placeboActive comparator 2 interventions
Group B: Low-dose psilocybin + placeboActive comparator 2 interventions
Group C: High-dose psilocybin + risperidoneExperimental treatment 2 interventions
Group D: Low-dose psilocybin + risperidoneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Positive effects

Persisting Effects Questionnaire (PEQ) - 145 questions rated using a 6-point Likert scale from 0 to 6. There are 12 sub-scale themes assessing positive and negative changes in Attitudes About Life, Attitudes About Self, Mood Changes, Social Effects, Behavioural Changes, and Spirituality. Higher scores in the positive sub-scales indicate a better outcome, while higher scores in the negative sub-scales indicate a worse outcome.

Time frame
One week and one month post-dosing

Secondary outcomes

1

Stress reactivity

Stress reactivity will be assessed through heart rate variability

Time frame
From start of dosing session to end of dosing session
2

Biomarkers of stress and plasticity

cortisol, ACTH, BDNF

Time frame
from baseline to dosing session (one week post-baseline) to follow-up 1 (one week post doing session) to follow-up 2 (one month post dosing session)
3

Mood

Mood will be assessed using the Positive and Negative Affect Schedule. The questionnaire has two sub-scales: the positive affect score (scores range from 10-50, higher scores represent better outcome) and the negative affect score (scores range from 10-50, higher scores represent worse outcome)

Time frame
from baseline to one week and one month post-dosing
4

Well-being

Well-being will be assessed using the Warwick-Edinburgh Mental Wellbeing Scale. The total score ranges from 14-70; a higher score represents a better outcome.

Time frame
from baseline to one week and one month post-dosing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov
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