Clinical trial NCT05317689: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: Psilocybin
Psilocin
Psilocybin Therapy
Psychedelics
Healthy
San Francisco
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Filament Health Corp.
First posted: 2022-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Physiological Effects
timeFrame: Baseline to 8 hours following drug delivery
measure: Physiological Effects
timeFrame: Baseline to 8 hours following drug delivery
measure: Psychological Effects
timeFrame: Baseline to 4 weeks after drug delivery
measure: Psychological Effects
timeFrame: Baseline to 4 weeks after drug delivery
measure: Psychological Effects
timeFrame: Baseline to 4 weeks after drug delivery
measure: Psychological Effects
timeFrame: Baseline to 4 weeks after drug delivery
measure: Psychological Effects
timeFrame: Baseline to 4 weeks after drug delivery
measure: Adverse Effects
timeFrame: Baseline to 24 hours after dosing session
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joshua Woolley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
citation: 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.