← Back to Search

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
No Placebo-Only Group

Summary

This trial is testing psilocybin, taken as a pill or through an IV, in healthy adults. The study aims to see how the body absorbs it and its effects. Psilocybin turns into psilocin in the body, which causes the psychedelic experience. Psilocybin is a naturally occurring tryptamine known for its psychedelic properties and has been studied for its potential to treat depression and anxiety.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,221 Previous Clinical Trials
3,167,485 Total Patients Enrolled
Christopher Nicholas, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
17 Total Patients Enrolled
~0 spots leftby Oct 2025