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Psychedelic

Psilocin vs. Psilocybin Effects in Healthy Adults

Phase 1

Recruiting

Led By Joshua Woolley, MD/PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No planned surgeries during the study

Age 25 to 50

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 hours after dosing session

Awards & highlights

Study Summary

This trial will compare the effects of psilocybin (taken as a pill) and psilocin (taken either as a pill or by dissolving a tablet under the tongue) on the physiology and psychology of healthy adults.

Who is the study for?

This trial is for healthy adults aged 25-50 who are comfortable with English, have had a psychedelic experience before, and can commit to all study visits. They must not use THC, CBD, or nicotine during the study and should not be on certain medications like dopamine agonists or MAO inhibitors.Check my eligibility

What is being tested?

The trial aims to compare the effects of psilocin taken orally or sublingually with those of psilocybin in pill form. It will assess both physiological and psychological responses in participants.See study design

What are the potential side effects?

Potential side effects may include changes in perception, mood swings, nausea, headaches, increased heart rate and blood pressure. These substances can also cause anxiety or distressing experiences known as 'bad trips'.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any surgeries planned during the study period.

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I am between 25 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 hours after dosing session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 hours after dosing session

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 hours after dosing session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Effects

Physiological Effects

Psychological Effects

Trial Design

2Treatment groups

Active Control

Group I: Oral & Sublingual Psilocin, & Oral PsilocybinActive Control3 Interventions

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

Group II: Sublingual PsilocinActive Control1 Intervention

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

0 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,535 Total Patients Enrolled

Filament HealthUNKNOWN

1 Previous Clinical Trials

100 Total Patients Enrolled

Joshua Woolley, MD/PhDPrincipal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Psilocin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05317689 — Phase 1

Healthy Subjects Research Study Groups: Oral & Sublingual Psilocin, & Oral Psilocybin, Sublingual Psilocin

Healthy Subjects Clinical Trial 2023: Psilocin Highlights & Side Effects. Trial Name: NCT05317689 — Phase 1

Psilocin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317689 — Phase 1

Healthy Subjects Patient Testimony for trial: Trial Name: NCT05317689 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this trial?

"Affirmative. According to the information on clinicaltrials.gov, this medical research is still open for recruitment and was initially posted in May 26th 2022. The study requires 20 participants from a single site, with the latest update being October 11th 2022."

Answered by AI

Has the FDA sanctioned either oral or sublingual psilocin, and/or oral psilocybin?

"Due to limited data on safety and efficacy, our team has given Oral & Sublingual Psilocin, & Oral Psilocybin a rating of 1. This is in accordance with the Phase 1 trial designation."

Answered by AI

Is there a possibility for me to join this trial?

"Eligible participants should be between 25 and 50 years of age, with healthy subjects (hs). This investigation is willing to accept 20 individuals."

Answered by AI

Is this trial open to participants who are of legal age?

"This medical trial requires that enrolled participants are within the age range of 25 to 50. Other trials exist for those under 18 and more than 373 studies include elderly patients above 65 years old."

Answered by AI

Are there still openings available for this trial?

"Per the clinical trials website, this research study is actively enrolling individuals. It was first posted on May 26th 2022 and has been modified as recently as October 11th 2022."

Answered by AI

Who else is applying?

What state do they live in?

Illinois

Ohio

Other

California

How old are they?

65+

18 - 65

What site did they apply to?

University of California, San Francisco

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

At a crossroads in my life. I am hoping to learn more about myself. Interested in effects of this compound.

PatientReceived no prior treatments

I believe this drug can offer positive improvements for peoples lives.

PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many visits will be required? What are the doses we would be taking? What is the overall purpose of this study?

PatientReceived 2+ prior treatments

Do you have a current or upcoming trial for someone aged 61? What exactly is the trial? What is expected of me? and what will my environment be like ?

PatientReceived 1 prior treatment