Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

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

Tracking Information

• First Submitted Date: March 7, 2022
• First Posted Date: April 8, 2022
• Last Update Posted Date: June 8, 2022
• Actual Study Start Date: May 26, 2022
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing the Effects of Psilocin and Psilocybin in Healthy Adults
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: Healthy

Intervention

• 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

• 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 *

• Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct.
• Barrett FS, Bradstreet MP, Leoutsakos JS, Johnson MW, Griffiths RR. The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms. J Psychopharmacol. 2016 Dec;30(12):1279-1295. Epub 2016 Nov 17.
• Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177/0269881115609019. Epub 2015 Oct 6.
• Benet-Martínez V, John OP. Los Cinco Grandes across cultures and ethnic groups: multitrait multimethod analyses of the Big Five in Spanish and English. J Pers Soc Psychol. 1998 Sep;75(3):729-50.
• Bogenschutz MP, Johnson MW. Classic hallucinogens in the treatment of addictions. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:250-8. doi: 10.1016/j.pnpbp.2015.03.002. Epub 2015 Mar 14. Review.
• Bogenschutz MP, Ross S. Therapeutic Applications of Classic Hallucinogens. Curr Top Behav Neurosci. 2018;36:361-391. doi: 10.1007/7854_2016_464. Review.
• Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 30, 2022): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05317689
• Other Study ID Numbers: 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

• 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: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Filament Health

Investigators

• 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