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Psilocybin for Pharmacokinetics

Phase 1
Waitlist Available
Research Sponsored by Usona Institute
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 up to 30 days post dose

Summary

This trial studies the effects of psilocybin, a compound from certain mushrooms, on heart function and its absorption with food. Healthy adults are tested to see how it changes brain function and perception. Psilocybin is a naturally occurring substance found in certain mushrooms, known for its hallucinogenic effects and potential therapeutic benefits.

Eligible Conditions
  • Pharmacokinetics
  • Long QT syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin.
Part 2: Change from baseline (T=0 hours) of AUC of psilocybin and its metabolite psilocin following up to 24 hours post administration of a therapeutic dose of psilocybin under fed and fasted conditions.
Part 2: Change from baseline (T=0 hours) of Cmax of psilocybin and its metabolite psilocin following up to 24 hours post administration of a therapeutic dose of psilocybin under fed and fasted conditions.
+1 more
Secondary study objectives
Part 1: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0.
Part 2: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0

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

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part 2: IP at Therapeutic Dose (Fed Conditions)Experimental Treatment1 Intervention
A single therapeutic dose of psilocybin under fed conditions.
Group II: Part 2: IP at Therapeutic Dose (Fasted Conditions)Experimental Treatment1 Intervention
A single therapeutic dose of psilocybin administered under fasted conditions.
Group III: Part 1: Treatment B (IP at Supratherapeutic Dose)Experimental Treatment1 Intervention
A single supratherapeutic dose of psilocybin.
Group IV: Part 1: Treatment A (IP at Therapeutic Dose)Experimental Treatment1 Intervention
A single therapeutic dose of psilocybin.
Group V: Part 1: Treatment D (Placebo - Positive Control)Active Control1 Intervention
A single 400 mg dose of moxifloxacin.
Group VI: Part 1: Treatment C (Placebo - Negative Control)Placebo Group1 Intervention
A single dose of placebo-to-match psilocybin MCC capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Usona InstituteLead Sponsor
15 Previous Clinical Trials
917 Total Patients Enrolled
1 Trials studying Pharmacokinetics
54 Patients Enrolled for Pharmacokinetics
Charles Raison, MDStudy DirectorUsona Institute
16 Previous Clinical Trials
881 Total Patients Enrolled
~18 spots leftby Nov 2025
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