This is a follow up to my January 2019 article, “Are we on the verge of a psychedelic revolution in mainstream psychiatry?” The answer to that question it turns out is not so fast.
Studies are continuing for the use of psilocybin for depression and MDMA (Ecstasy) for PTSD; the latter just finished Phase 2 with 54.2% of treated subjects no longer qualifying for a PTSD diagnosis (vs 22.6% of placebo). The results are so impressive that the FDA fast tracked this treatment and Phase 3 is beginning. The hope was FDA approval might come in 2021 but now it appears the more realistic timeline is 2023 or 2024. The same applies for the psilocybin studies with active Phase 2 studies for Major Depressive Disorder in multiple sites throughout the U.S. and U.K. with approval estimated to be in 2023-2024. Once these medicines are approved they will only be used by specially trained clinicians and will require additional monitoring by the FDA. They will never be take home drugs and can only be used in a clinic setting.
Recent studies are also clarifying how psychedelics work in the brain. There is increasing confidence that the target receptor is Serotonin 2A. There are at least 14 different serotonin receptor subtypes that SSRIs (serotonin reuptake inhibitors like Prozac) potentially work on. There is some discussion now that the Serotonin 2A receptor represents a pivotal mental state from not just getting by (such as with SSRIs that tend to mitigate stress) but instead leads to transformation. The working model is that this transformation is not just about the psychedelic itself but the therapy one receives under psychedelics which has a synergistic effect.
All of us have certain belief systems or habits/biases in how we see the world. The predictive processing model about why we learn hypothesizes that the brain evolved as a prediction machine. In other words, over time our brains are presented with sometimes incomplete information and certain assumptions had to be made to make sense of the world. For example, if a child is being teased by a classmate, an adaptive learning response could be “people can hurt you, caution is sometimes warranted.” A maladaptive learning response would be “people will always hurt you, you are worthless, everything is scary, it will never get better.” The predictive processing model can also explain how psychedelics transform people: when people have these inner negative heavily weighted beliefs, they develop mental health problems such as addiction, eating disorder, trauma or depression. A person is then able to lubricate and relax these belief structures without fear during a psychedelic drug session and with the help of a therapist is able to revise these beliefs after the psychedelic session is completed. We still don’t have long term outcomes about what happens to these changes over time.
What would the psychedelic assisted therapy session look like? There are actually 3 components to treatment: 1) Preparation (6-8 hours): 2 therapists would be assigned to 1 patient to create a safe space, build trust and set intentions, 2) Drug session itself (6-10 hours) where the philosophy is to “trust, let go, be open” with the patient laying on a couch or table wearing an eye mask and headphones with music to set emotional tone with the therapists present. The last component: 3) Integration (4-6 hours) with the therapists assisting to make sense of the journey, observe behavioral changes in the after flow, and help with grounding and transition back to day to day life. This special training for clinicians is already happening across the U.S. and will continue to expand as preparation for FDA approval of psychedelics in the next few years.