A Phase 1 interventional study of Oral Psilocybin and IV Psilocybin in Healthy, sponsored by University of Wisconsin, Madison. Withdrawn at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Basic science
The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks.
Psilocybin, when delivered to screened and prepared participants in a controlled environment, has shown strong evidence of positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. Psilocybin is very rapidly transformed to the active metabolite psilocin, which is considered the active agent from psilocybin administration. Oral and IV psilocybin are expected to have similar pharmacokinetic and psychedelic effects, as well as safety profiles, while IV psilocybin will achieve more consistent blood levels than are possible with oral psilocybin.
University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Oral Psilocybin · Drug: IV Psilocybin
25mg orally
5mg intravenously
Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin
Determine the maximum plasma concentration of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
Time frame: Day 8, Day 22
Determine the concentration of psilocin following oral and IV administrations of psilocybin
Determine the time to maximum plasma concentration of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
Time frame: Day 8, Day 22
Determine the concentration of psilocin following oral and IV administrations of psilocybin
Determine the half-life of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
Time frame: Day 8, Day 22
Determine the concentration of psilocin following oral and IV administrations of psilocybin
Determine the AUC of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
Time frame: Day 8, Day 22
Difference in the area under plasma concentration-time curve (AUC) between psilocybin administration methods.
AUC will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
Time frame: Day 8, Day 22
Difference in the maximum concentration (Cmax) between psilocybin administration methods.
Cmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
Time frame: Day 8, Day 22
Difference in the time to maximum plasma concentration (Tmax) between psilocybin administration methods.
Tmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
Time frame: Day 8, Day 22
Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults
The incidence and severity of expected and unexpected adverse events will be collected using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Time frame: 12 weeks
Suicidal ideation
Assessed using the Columbia - Suicide Severity Rating Scale (C-SSRS) at every in-person visit
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison