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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

Tracking Information
First Submitted Date  ICMJE March 7, 2022
First Posted Date  ICMJE April 8, 2022
Last Update Posted Date June 8, 2022
Actual Study Start Date  ICMJE May 26, 2022
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2022)
  • Physiological Effects [ Time Frame: Baseline to 8 hours following drug delivery ]
    blood pressure
  • Physiological Effects [ Time Frame: Baseline to 8 hours following drug delivery ]
    heart rate
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Effects of Psilocin and Psilocybin in Healthy Adults
Official Title  ICMJE Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Oral & Sublingual Psilocin, & Oral Psilocybin
    Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.
    Interventions:
    • Drug: Psilocin
    • Drug: Psilocybin
    • Drug: Sublingual Psilocin
  • 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.
    Intervention: Drug: Sublingual Psilocin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2022)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jacob Aday 415-221-4810 ext 24117 psilocybinstudies@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05317689
Other Study ID Numbers  ICMJE IRB#21-33765
PR#202143H ( Other Identifier: Research Advisory Panel - California )
156917 ( Other Identifier: FDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Joshua Woolley, MD/PhD, University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Filament Health
Investigators  ICMJE
Principal Investigator: Joshua Woolley University of California, San Francisco
Study Chair: Jacob Aday University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP