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Oral Psilocybin for Healthy Subjects

Phase 1
Waitlist Available
Led By Christopher Nicholas, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8, day 22
Awards & highlights

Study Summary

This trial is testing whether psilocybin is more effective when taken orally or intravenously. Researchers will also study the participants' psychedelic experience and any side effects. The trial will last 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8, day 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8, day 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the concentration of psilocin following oral and IV administrations of psilocybin
Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin
Difference in the area under plasma concentration-time curve (AUC) between psilocybin administration methods.
+2 more
Secondary outcome measures
Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults
Suicidal ideation

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral and IV psilocybinExperimental Treatment2 Interventions
Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water, at one visit. Psilocybin will be administered through IV at the other visit.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TRYP TherapeuticsIndustry Sponsor
3 Previous Clinical Trials
34 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,546 Total Patients Enrolled
Christopher Nicholas, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
17 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must be met in order to participate in this experiment?

"This clinical trial is enrolling 8 individuals aged 25-65 with hs status. In addition, they must be medically stable and have the capacity to give informed consent; persons of childbearing potential also require a negative urine pregnancy test."

Answered by AI

Is this study open to new participants?

"Per the clinicaltrials.gov website, this research study is not currently accepting patient applications. The trial was first posted on January 1st 2023 and last updated on October 24th 2022, however there are 840 other active trials searching for volunteers across the world now."

Answered by AI

What potential hazards exist for those taking Oral Psilocybin?

"The safety of Oral Psilocybin is rated a 1, as this trial only has modest evidence in regards to efficacy and limited data concerning its safety."

Answered by AI

Is the enrollment for this medical study limited to those aged fifty-five and under?

"As per the prerequisites for enrollment, all participants must be aged between 25 and 65."

Answered by AI

Who else is applying?

What state do they live in?
California
Illinois
Wisconsin
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

I am interested in helping with medical research. Curious as to the healing potential of this compound.
PatientReceived 2+ prior treatments
I have long wanted to try psilocybin to treat my long standing depression.
PatientReceived no prior treatments
I would love to take part in clinical trials, and I'm fascinated by psilocybin.
PatientReceived 2+ prior treatments
I believe in this research and hope this type of medicine can help others in the future.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When do you expect this trial to begin? Is it 12 weeks staying at the test center?
PatientReceived 2+ prior treatments
I work full-time. Are we compensated at all? What about travel expenses? How many visits in the 12 week study period? And how long is each visit?
PatientReceived 2+ prior treatments
When does it start ? How many does will be administered? How long is it ?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Wisconsin: < 48 hours
Average response time
  • < 2 Days
~0 spots leftby Apr 2025