Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

Psilocybin

Brief Summary

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.

Intervention / Treatment

  • Psilocin (DRUG)
    17.5mg oral psilocin with psychological support and physiological monitoring
  • Psilocybin (DRUG)
    25mg oral psilocybin with psychological support and physiological monitoring
  • Sublingual Psilocin (DRUG)
    2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring

Condition or Disease

  • Healthy

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 25 Years to 50 Years
    Enrollment: 20 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 26, 2022 ACTUAL
    Primary Completion: Dec 01, 2024 ESTIMATED
    Completion Date: Dec 01, 2024 ESTIMATED
    Study First Posted: Apr 08, 2022 ACTUAL
    Last Updated: Oct 11, 2022

    Sponsors / Collaborators

    Lead Sponsor: University of California, San Francisco
    Responsible Party: N/A

    Location

    San Francisco, California, USA

    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.

    Participant Groups

    • Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.

    • Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time.

    Eligibility Criteria

    Sex: All
    Minimum Age: 25
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • blood pressure

    • heart rate

    • - Peak psychedelic intensity ratings will be measured using Likert scale (0-10 rating scale, 0=not intense at all, 10=highest intensity imaginable)

    • - Peak psychological effects will be measured by the Altered States of Consciousness (5D-ASC) questionnaire at the end of each dosing session

    • - Peak psychological effects will be measured by the Challenging Experiences Questionnaire at the end of each dosing session

    • - Persistent changes in attitude, mood, and behavior will be assessed using Persisting Effects Questionnaire, administered 4 weeks after each dosing session

    • - Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session

    • * 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

    More Details

    NCT Number: NCT05317689
    Other IDs: IRB#21-33765
    Study URL: https://clinicaltrials.gov/study/NCT05317689
    Last updated: Sep 29, 2023