Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

Healthy Clinical Trial

Official title:

Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317689
• Other study ID #: IRB#21-33765
• Secondary ID: PR#202143H156917
• Status: Recruiting
• Phase: Phase 1
• Start date: May 26, 2022
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: Cesar Molina
• Phone: 415-221-4810
• Email: psilocybinstudies[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Filament Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. doi: 10.1177/0269881116678781. Epub 2016 Nov 17. — View Citation

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. — View Citation

Benet-Martinez 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. doi: 10.1037//0022-3514.75.3.729. — View Citation

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. — View Citation

Bogenschutz MP, Ross S. Therapeutic Applications of Classic Hallucinogens. Curr Top Behav Neurosci. 2018;36:361-391. doi: 10.1007/7854_2016_464. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological Effects	blood pressure	Baseline to 8 hours following drug delivery
Primary	Physiological Effects	heart rate	Baseline to 8 hours following drug delivery
Primary	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)	Baseline to 4 weeks after drug delivery
Primary	Psychological Effects	- Peak psychological effects will be measured by the Altered States of Consciousness (5D-ASC) questionnaire at the end of each dosing session	Baseline to 4 weeks after drug delivery
Primary	Psychological Effects	- Peak psychological effects will be measured by the Challenging Experiences Questionnaire at the end of each dosing session	Baseline to 4 weeks after drug delivery
Primary	Psychological Effects	- Persistent changes in attitude, mood, and behavior will be assessed using Persisting Effects Questionnaire, administered 4 weeks after each dosing session	Baseline to 4 weeks after drug delivery
Primary	Psychological Effects	- Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session	Baseline to 4 weeks after drug delivery
Primary	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	Baseline to 24 hours after dosing session

External Links

•   Individuals interested in participating in the clinical trial, please notify the study team of interest by completing the pre-screening survey on the website located under the specific study heading.