This pilot study aims to establish a dosing regimen for intravenous (IV) psilocybin that will allow the drug to be administered to asleep participants without awakening them and assess whether this dosing regimen produces a psychedelic experience.
Healthy participants (n=15) will be administered 2 mg of psilocybin via IV infusion and left to sleep for 1 hour. If participants’ sleep is disturbed, dosing strategies will be reassessed.
This is the latest trial at the University of Wisconsin-Madison in collaboration with the Usona Institute.
Topic Neuroscience
Compound Psilocybin
Country United States of America
Visit trial
Status
Not yet recruiting
Results Published
No
Start date
01 March 2023
End date
01 December 2023
Chance of happening
85%
Phase
Phase I
Design
Open
Type
Interventional
Generation
First
Participants
15
Sex
All
Age
18- 40
Therapy
No
Trial Details
The study intervention will be psilocybin administered by the intravenous (IV) route to sleeping and awake participants. The study will test up to two different IV administration protocols in sleeping participants. The first protocol to be tested will consist of 2 mg of psilocybin administered via IV infusion over a 2-minute period. Should this method allow participants to remain asleep for at least 1 hour post-dosing, no further dosing strategies will be evaluated. If the 2-minute IV infusion delivery method disrupts sleep, a second dosing strategy will be examined consisting of 2 mg of IV psilocybin administered over 10 minutes. Whichever dosing strategy causes the least sleep disruption will be selected for administration to awake participants. As part of the study design, some participants may also receive normal IV saline instead of IV psilocybin during the dosing session. For any given participant, the protocol for delivering the normal saline will be identical to the psilocybin protocol they receive (e.g., either IV saline (10 mL) over 2 minutes or IV saline (10 mL) over 10 minute IV infusion). Participants will include medically and psychiatrically healthy biological males and females of any identified gender and racial/ethnic group aged 18 to 40 years.NCT Number NCT05592379
Sponsors & Collaborators
Usona InstituteThe Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).
University of Wisconsin-Madison
The Transdisciplinary Center for Research in Psychoactive Substances (TCRPS) was launched at the University of Wisconsin-Madison in 2021.