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Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

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ClinicalTrials.gov Identifier: NCT05317689
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : June 8, 2022
Sponsor:
Collaborator:
Filament Health
Information provided by (Responsible Party):
Joshua Woolley, MD/PhD, University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Psilocin Drug: Psilocybin Drug: Sublingual Psilocin Phase 1

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Oral & Sublingual Psilocin, & Oral Psilocybin
Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.
 Drug: Psilocin
17.5mg oral psilocin with psychological support and physiological monitoring

Drug: Psilocybin
25mg oral psilocybin with psychological support and physiological monitoring

Drug: Sublingual Psilocin
2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring
Active Comparator: Sublingual Psilocin
Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time.
 Drug: Sublingual Psilocin
2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring


Outcome Measures
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Primary Outcome Measures :
  1. Physiological Effects [ Time Frame: Baseline to 8 hours following drug delivery ]
    blood pressure

  2. Physiological Effects [ Time Frame: Baseline to 8 hours following drug delivery ]
    heart rate

  3. Psychological Effects [ Time Frame: Baseline to 4 weeks after drug delivery ]
    - Peak psychedelic intensity ratings will be measured using Likert scale (0-10 rating scale, 0=not intense at all, 10=highest intensity imaginable)

  4. Psychological Effects [ Time Frame: Baseline to 4 weeks after drug delivery ]
    - Peak psychological effects will be measured by the Altered States of Consciousness (5D-ASC) questionnaire at the end of each dosing session

  5. Psychological Effects [ Time Frame: Baseline to 4 weeks after drug delivery ]
    - Peak psychological effects will be measured by the Challenging Experiences Questionnaire at the end of each dosing session

  6. Psychological Effects [ Time Frame: Baseline to 4 weeks after drug delivery ]
    - Persistent changes in attitude, mood, and behavior will be assessed using Persisting Effects Questionnaire, administered 4 weeks after each dosing session

  7. Psychological Effects [ Time Frame: Baseline to 4 weeks after drug delivery ]
    - Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session

  8. Adverse Effects [ Time Frame: Baseline to 24 hours after 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05317689


Contacts
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Contact: Jacob Aday 415-221-4810 ext 24117 psilocybinstudies@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jake Aday    415-942-0820      
Contact: Josh Woolley    415-221-4810 ext 24117      
Sponsors and Collaborators
University of California, San Francisco
Filament Health
Investigators
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Principal Investigator: Joshua Woolley University of California, San Francisco
Study Chair: Jacob Aday University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Joshua Woolley, MD/PhD, University of California, San Francisco:
Informed Consent Form  [PDF] May 3, 2022

More Information
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Publications:

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Responsible Party: Joshua Woolley, MD/PhD, Associate Professor, Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05317689    
Other Study ID Numbers: IRB#21-33765
PR#202143H ( Other Identifier: Research Advisory Panel - California )
156917 ( Other Identifier: FDA )
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua Woolley, MD/PhD, University of California, San Francisco:
Psilocybin
Psilocin
Psilocybin Therapy
 Psychedelics
Healthy
San Francisco
Additional relevant MeSH terms:
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Psilocybin
Psilocin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs