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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
20
17.5mg oral psilocin with psychological support and physiological monitoring
25mg oral psilocybin with psychological support and physiological monitoring
2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring
University of California, San Francisco
San Francisco, California, United States
Physiological Effects
blood pressure
Time frame: Baseline to 8 hours following drug delivery
Physiological Effects
heart rate
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: Baseline to 24 hours after dosing session