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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

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%
Oropharyngeal pain
4%
Suicidal Ideation
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%
Rhinorrhea
2%
Musculoskeletal pain
2%
Oedema
2%
Pyrexia
2%
Peripheral swelling
2%
Restlessness
2%
Vomiting
2%
Fungal infection
2%
Hypoesthesia
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.

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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
1,198 Previous Clinical Trials
3,162,264 Total Patients Enrolled
Christopher Nicholas, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
17 Total Patients Enrolled
~0 spots leftby Jul 2025