Summary

Eligibility
for people ages 25-50 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion
Principal Investigator
by Joshua WoolleyJacob Aday
Headshot of Joshua Woolley
Joshua Woolley
Headshot of Jacob Aday
Jacob Aday

Description

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.

Official Title

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

Details

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.

Keywords

Healthy Psilocybin Psilocin Psilocybin Therapy Psychedelics Sublingual Psilocin Oral & Sublingual Psilocin, & Oral Psilocybin

Eligibility

You can join if…

Open to people ages 25-50

  • Age 25 to 50
  • Comfortable speaking and writing in English
  • Commit to attending all study visits and remote data collection tasks
  • Had at least one prior experience with a psychedelic substance
  • No planned surgeries during the study
  • Agree to abstain from THC, CBD, or nicotine products during study

You CAN'T join if...

  • Meeting criteria over the last year for any mood, anxiety, or personality disorder
  • History of medication or drug induced psychosis
  • First degree relative (parent or sibling) with clinical diagnosis of bipolar disorder or schizophrenia
  • Participated in another clinical trial within 30 days of entry to this trial
  • History of using any psychedelic substances within the past year
  • 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
  • Current diagnosis of epilepsy or other seizure disorder

Lead Scientists at UCSF

  • Joshua Woolley
    Dr. Josh Woolley is an Associate Professor in Residence in the Department of Psychiatry and Behavioral Sciences at the University of California, San Francisco (UCSF) as well as a staff psychiatrist in Mental Health at the San Francisco Veterans Affairs Medical Center (SFVAMC). He is Board Certified in Psychiatry by the American Board of Psychiatry and Neurology.
  • Jacob Aday
    Postdoctoral Scholar, Psychiatry, School of Medicine. Authored (or co-authored) 15 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05317689
Phase
Phase 1 Psilocybin Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated