NCT05317689

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2022

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 10, 2025

Status Verified

September 1, 2024

Enrollment Period

2.6 years

First QC Date

March 7, 2022

Last Update Submit

June 5, 2025

Conditions

Healthy

Keywords

PsilocybinPsilocinPsilocybin TherapyPsychedelicsHealthySan Francisco

Outcome Measures

Primary Outcomes (8)

  • Physiological Effects

    blood pressure

    Baseline to 8 hours following drug delivery

  • Physiological Effects

    heart rate

    Baseline to 8 hours following drug delivery

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Oral & Sublingual Psilocin, & Oral Psilocybin

ACTIVE COMPARATOR

Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.

Drug: PsilocinDrug: PsilocybinDrug: Sublingual Psilocin

Sublingual Psilocin

ACTIVE COMPARATOR

Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time.

Drug: Sublingual Psilocin

Interventions

PsilocinDRUG

17.5mg oral psilocin with psychological support and physiological monitoring

Oral & Sublingual Psilocin, & Oral Psilocybin
PsilocybinDRUG

25mg oral psilocybin with psychological support and physiological monitoring

Oral & Sublingual Psilocin, & Oral Psilocybin
Sublingual PsilocinDRUG

2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring

Oral & Sublingual Psilocin, & Oral PsilocybinSublingual Psilocin

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

  • 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.

    PMID: 25784600BACKGROUND

  • 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.

    PMID: 9781409BACKGROUND

  • 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.

    PMID: 28353056BACKGROUND

  • 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.

    PMID: 27856683BACKGROUND

  • 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.

    PMID: 33150319BACKGROUND

MeSH Terms

Interventions

psilocinPsilocybin

Intervention Hierarchy (Ancestors)

Indole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTryptaminesIndolizidinesIndolizines

Study Officials

  • Joshua Woolley, MD/PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Psychiatry

Study Record Dates

First Submitted

March 7, 2022

First Posted

April 8, 2022

Study Start

May 26, 2022

Primary Completion

January 16, 2025

Study Completion

July 1, 2025

Last Updated

June 10, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)