Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

Study Overview
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Brief Summary
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To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults.

Detailed Description
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The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant.

Official Title
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Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: Psilocin
* Drug: Psilocybin
* Drug: Sublingual Psilocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25 to 50 Comfortable speaking and writing in English Commit to attending all study visits and remote data collection tasks No planned surgeries during the study Had at least one prior experience with a psychedelic substance Generally mentally and physically healthy Agree to abstain from THC, CBD, or nicotine products during study Exclusion Criteria: Participated in another clinical trial within 30 days of entry to this trial Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants A health condition that makes study unsafe or unfeasible, determined by study physicians

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral & Sublingual Psilocin, & Oral Psilocybin<br>Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order. | Drug: Psilocin<br>* 17.5mg oral psilocin with psychological support and physiological monitoring<br>Drug: Psilocybin<br>* 25mg oral psilocybin with psychological support and physiological monitoring<br>Drug: Sublingual Psilocin<br>* 2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring<br>|
| Active Comparator: Sublingual Psilocin<br>Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time. | Drug: Sublingual Psilocin<br>* 2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological Effects | blood pressure | Baseline to 8 hours following drug delivery | 
| Physiological Effects | heart rate | Baseline to 8 hours following drug delivery | 
| Psychological Effects | - Peak psychedelic intensity ratings will be measured using Likert scale (0-10 rating scale, 0=not intense at all, 10=highest intensity imaginable) | Baseline to 4 weeks after drug delivery | 
| Psychological Effects | - Peak psychological effects will be measured by the Altered States of Consciousness (5D-ASC) questionnaire at the end of each dosing session | Baseline to 4 weeks after drug delivery | 
| Psychological Effects | - Peak psychological effects will be measured by the Challenging Experiences Questionnaire at the end of each dosing session | Baseline to 4 weeks after drug delivery | 
| Psychological Effects | - Persistent changes in attitude, mood, and behavior will be assessed using Persisting Effects Questionnaire, administered 4 weeks after each dosing session | Baseline to 4 weeks after drug delivery | 
| Psychological Effects | - Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session | Baseline to 4 weeks after drug delivery | 
| Adverse Effects | Acute hypertension, hypotension, tachycardia, or bradycardia will be detected through blood pressure and heart rate monitoring at 10 minutes prior to drug administration and measured frequently up to 360 minutes following administration Other dosing-related side effects including descriptive reports of nausea, headaches, dizziness, weakness, drowsiness, paresthesia, or blurred vision will be assessed during check-ins, after dosing effects have waned, and 24 hours following dosing | Baseline to 24 hours after dosing session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psilocybin, Psilocin, Psilocybin Therapy, Psychedelics, Healthy, San Francisco