Clinical Research, My Experience
In early 2022, I was contacted by AltaSciences about clinical research on psychedelic medicine starting later that year at their site in Overland Park, KS. There weren’t many details initially provided about this project. I have since learned that clinical trials in pharmaceutical research are very confidential until the data are reviewed and published. (No part of this post violates my non-disclosure agreement). After an interview process with the investigator, AltaSciences, and the study sponsor, Usona, I was hired to be a lead facilitator.
I became part of a team of lead facilitators and co-facilitators. The training and preparation to do this work was extensive. The study sponsor invested heavily in preparing the facilitation team to work with the study subjects and the medicines.
The first medicine that we worked with was psilocybin. Although there is an extensive body of research on psilocybin, this was a phase 1 trial to study pharmacokinetics followed by ADME (absorption, digestion, metabolism, elimination) or what was referred to as “food effects.”
The second medicine we studied was 5-MeO-DMT. This was the first in human study for this molecule, although there is a long history of use of the medicine in naturalistic settings. In those settings and colloquially, it is referred to as “smoking toad.” No toads were harmed in this process.
Both medicines in the study were synthetic opposed to natural products. It should be noted that Usona uses an “open sciences framework” and shares their research in the spirit of collaboration.
There were so many interesting and moving aspects of being part of this. Not the least of which is the fact that it was in Overland Park, KS. When I was trained in ketamine assisted psychotherapy (KAP) in 2019, the clinical landscape for working with psychedelics was limited in the Midwest. I gained insight into the process and all the moving parts of a phase 1 clinical trial. The AltaSciences staff were great to work with. This was a new paradigm for them. We, the facilitators, came into their workplace, unfamiliar with their processes. They were helpful and professional. The sponsor, Usona, was supportive. I had the privilege of meeting and working with some wise and well-informed people from Usona. After a few years in private practice, it was nice to be on a team. Working with the other facilitators became intuitive and we communicated often with only eye contact.
I was particularly moved by the study subjects, yes, that’s what they are called in this setting. They are people that answer those adds: “Are you a healthy adult, ages 18 to 55…” Many of the subjects travel by train, bus, or from neighboring states in the summer with no air conditioning in their car to get to the study. In these studies, they made repeat trips. Many are regular participants in clinical trials. They give their time, bodies, and in the case of psychedelic medicine, their minds, to advance science and medicine. They are paid for this, as they should be. I was amazed and humbled by each of them. There are some that I will never forget.
In the psychedelic space, there is tension between underground and clinical work, natural and synthesized medicines, shamans and licensed clinicians, the past and the future. These are healthy discussions that will continue. However, this process will establish safety and expand access. It was exhausting, challenging, heavy, joyful and awe inspiring.
My first day on the study site was April 19, 2022. My last day will be September 7, 2023. I leave with insight, gratitude, and hope.
You can learn more about these trials at https://clinicaltrials.gov.