Behind the Scenes of Being a Clinical Trial Participant

In a video interview with Pharma Commerce, Jon Kostas,executive director of the APP, discusses how the main goals and priorities of the APP are to serve as a trusted industry voice in the realm of psychedelics, aiming to provide clarity in an area that is often confusing due to the wide range of information and varying compounds. The organization seeks to advance psychedelic treatments through the FDA approval process, making these therapies accessible, affordable, and covered by insurance. In addition to expanding access, the APP emphasizes patient safety, ensuring that individuals receive the correct dosage and undergo appropriate mental and physical screenings before treatment. The focus is also on establishing best practices and safety standards for psychedelic use, ensuring that only eligible and qualified patients pursue these treatments.

Kostas also explains why he believes there was a need for this type of resource, what went into the making the launch happen, and the current state of psychedelic research, while sharing a personal story surrounding his participation in a randomized clinical trial involving psilocybin.

A transcript of Kostas’ conversation with PC can be found below.

PC: Could you describe the double-blind, randomized clinical trial involving psilocybin that you participated in?

Kostas: Start to finish, it was about 54 weeks, and then I believe we took like a five or so month break in between. How it worked was, I went in for a screening. I had about a month or two of preparation to get me ready on what I might experience during these psilocybin sessions, because they give you a high dose of psilocybin (if you get the psilocybin and you don't get the placebo). That's why we're really emphasizing the safety here, because there is hope. This saved my life, but I did this with medical doctors. I did this with PhDs. I did this in a hospital setting, so if anything bad were to happen, they'd know how to get me through it.

A lot of people should have hope that are struggling right now, or their family members are struggling, but I'd encourage them to do this through the proper channels, and right now, that's through FDA clinical trials. We’re on the cusp of FDA approval, so hopefully they can do this through the healthcare system in the near future, but you need preparation, and you need to be mentally prepared and physically healthy to go through these experiences.

That was a big part of the clinical trial I was in: the team, the psychological support, a lot of preparation, a lot of integration after, and the sessions themselves. I was there for about a whole day, I mean, eight hours, and you're really feeling the effects of the drugs for a good, maybe 4,5,6 hours, and then they keep you there to make sure you're okay. How I did this was that I was technically like an outpatient, where I showed up for the day in the morning, did my procedure, and then I had someone pick me up from the hospital after, so I think that's probably how it'll look and be implemented into our current system.