SUMMARY

SUMMARY Psychedelics have a long history of use in ritual and religious ceremonies, as well as plant-based treatment for a variety of physical and mental conditions in ancient cultures. Since the 1990’s the world has seen a marked increase in the interest of psychedelics and their potential in treating mental health conditions using psychedelic-assisted psychotherapy. As mental health condition statistics progressively rise, healthcare professionals continue to look for effective ways to treat patients, specifically treatment-resistant illness. COVID-19 has significantly increased symptoms of anxiety and depressive disorders, further necessitating the need for more effective, safe and tolerable treatments. Ongoing funding and sponsorship continue to grow as profit and non-profit organizations, including US and international research institutions, advocacy and educational groups, universities and private researchers collaborate in their commitment to investigate the safety and efficacy of psychedelics such as psilocybin and MDMA for their potential use in treating mental illness. The FDA has granted “Breakthrough Therapy” designation for the study of psilocybin and MDMA marking further progress towards possible therapeutic use. Moreover, the recent federal funding to NIDA for psychedelic research, represents an inflection point. Movements to decriminalize and legalize psychedelics, as already seen in states like Oregon and California, will likely only extend to other states and local governments if early studies continue to report promising data. Looking ahead, in 2023 MDMA-assisted psychotherapy for PTSD could reach a milestone if MAPS receives FDA approval. Preliminary clinical trial findings suggest psychedelic-assisted psychotherapy can be efficacious in treating mental health disorders such as PTSD, addiction, and MDD, but more robust studies, as well as comparative trials, are needed to evaluate their safety and efficacy and optimal dosing. For psychedelics to become mainstream, they would need to be validated in large-scale randomized controlled trials.