Timmy Davis

My personal interpretation of what psychological support means in connection to clinical trials looking at psychedelics. -Jake: Several companies are stressing that there is no psychotherapy DURING the dosing session and therefore “psychedelic-assisted therapy” isn’t the correct terminology to describe what happens in their clinical trials. Back in the 60’s, a lot of psychedelic assisted-psychotherapy was done with low doses of LSD (psycholytic therapy). Like with MDMA in Lykos’ trial, therapy was done during the dosing session. I think many companies use the term psychological support, to distinguish their investigational treatment from what I mentioned above (my personal opinion is that psychological support is therapy, but just not utilized during the actual dosing session/some may disagree with me here). The closest thing resembling therapy during the dosing session is perhaps when facilitators may reassure trial participants that they are safe, in the case of challenging experiences. I think by using the term psychological support, companies are positioning their treatments to the FDA in a way that stresses the importance of the drug. There is also reason to believe that the drug is doing a lot of the work (some may disagree with me here), as management at Compass, for example, will cite a sharp decline in MADRS scores the day after dosing (before any integration sessions have been done). Post-dose sessions may also be positioned as a safety measure, rather than structured psychotherapy. In a potential future FDA Adcomm for Psilocybin, I will be curious to see if there is a lot of discussion around the topic of psychological support. Will companies such as Compass be able to prove that the drug is doing much more work than the therapeutic support?