Current Studies
Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase – Madison, WI
This pilot study aims to 1) establish a dosing regimen for intravenous (IV) psilocybin that will allow the drug to be administered to asleep participants without awakening them; and 2) assess whether this dosing regimen produces a psychedelic experience.
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 45 years.
Those who may be interested in participating can find out more about the study on clinicaltrials.gov (ID NCT05592379) and/or complete our REDCap survey to see if you are eligible and be contacted by the study team.
Upcoming Studies
Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin (ENHANCE Study) – Madison, WI
The ultimate goal of this study is to test whether transauricular vagus nerve stimulation (taVNS), a known enhancer of neuroplasticity and memory recall, can enhance the long-term positive emotional meaningfulness and therapeutic potential of the psychedelic experience. Medically healthy participants will receive a single 25 mg dose of psilocybin followed by 1) taVNS treatment, 2) taVNS sham treatment, or 3) treatment as usual, depending on group assignment. All participants will complete a screening visit to determine eligibility, two baseline visits, a dosing visit, and three follow-up visits. taVNS or sham taVNS will be completed at home and monitored remotely by study personnel.
The term “perception box” noted in this study’s title is a metaphor created by Elizabeth Koch of the Tiny Blue Dot Foundation that is used to describe the perceptual constraints, such as unconscious assumptions and biases, that people absorb through the cultural norms established by their physical and social environment, which then contribute to their views of social reality.
“When its walls are contracted, our Perception Box becomes the source of much suffering, rumination, insensitivity to the experiences of others, and misinterpretation of one’s predicament and that of other sentient beings. We feel as though we are victims without agency, on the hunt for someone to blame. When its walls expand, we are open to the universe and to people.”
– Tiny Blue Dot Foundation
We use the concept of “expansion of the perception box” as a metaphor for a process whereby we adopt perspectives on the world that promote emotional wellbeing, both directly and via the encouragement of patterns of behavior that—other things being equal—create and reinforce wellbeing. While this study will examine the effects of adding taVNS to psilocybin to enhance perception box-relevant outcomes in healthy volunteers, the results of this research may be highly relevant for the future development of effective mental health therapies.
This study is made possible through grant funding provided by the Tiny Blue Dot (TBD) Foundation via a specific Request for Application (RFA) called “The Science of the Perception Box”.
Role of Experience, Conscious Awareness, and Plasticity in Psilocybin’s Long-Term Behavioral Effects – Follow-Up Study (RECAP 2 Study) – Madison, WI
This Phase 1, single site, prospective, randomized, double-blind, placebo-controlled trial is designed as a follow-up of the RECAP Pilot study that determined the optimal dose of Midazolam (a short-acting benzodiazepine) that allows a psychedelic experience while inducing amnesia during the psychedelic experience. In this new study, we will investigate the role of neuroplasticity in psilocybin-induced long-term effects on well-being.
To accomplish study aims, healthy adult volunteers with at least a modest decrement in emotional wellbeing and who meet inclusion/exclusion criteria will be randomized with equal allocation to one of four treatments:
- Group 1: Psilocybin (25 mg) + intravenous (IV) midazolam
- Group 2: Psilocybin (25 mg) + IV saline (placebo for midazolam)
- Group 3: Psilocybin (1 mg/control) + IV midazolam
- Group 4: Psilocybin (1 mg/control) + IV saline
Behavioral, neuroplasticity-related and memory-related study endpoints will be assessed at various timepoints after the psilocybin dosing day, and information on adverse events (AEs) will be collected at all assessment visits. On dosing day, subjects will be randomized to various combinations of psilocybin, psilocybin control, midazolam, and placebo, as outlined above. The psychedelic experience will be assessed in real time while it is occurring using brief questionnaires, narrative reports, and high-density EEG (hd-EEG). All treatment conditions will be delivered within a standard “set and setting” protocol that will include preparation sessions prior to, facilitation during, and integration sessions following dosing. Study participants will complete up to 8 study visits over the course of up to 75 days.
The Optimizing Psilocybin Study (OPT-IN) – Vail, Colorado
Through the establishment of The Vail Health Behavioral Health Innovation Center (BHIC), a collaboration between Vail Health and University of Wisconsin-Madison directed by Dr. Charles Raison, our research team will support the implementation of the OPT-IN Study which will examine novel ways to enhance the impact of psilocybin on depression and anxiety via co-administration of non-invasive vagus nerve stimulation.
To be conducted at the Vail Health BHIC, this study is unique in that it will also assess the impact of psilocybin on real-world social behavior and will use advanced strategies to better understand the risks and benefits of psilocybin use in a legalized setting, such as Colorado.