Advancing psychedelic clinical trials for patients struggling with serious medical illness and despair
Psychedelic therapies combine investigational medications like psilocybin with talk therapy in order to induce transcendent experiences and durable symptom relief. Psychedelic therapies may help patients with treatment-resistant conditions experience rapid and profound improvements in their coping and quality of life through catalyzing shifts in their belief systems that lead to a greater sense of peace with oneself, others, or the Beyond.
Currently, CURA is co-coordinating with Dr. Charles Grob and colleagues at the Lundquist Institute at Harbor-UCLA the Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC), an actively enrolling, 5-site trial for demoralized adults near the end of life. This trial has innovated in several areas of investigator-initiated trial design and operations, including use of a psychoactive control drug (ketamine) to address functional unblinding, developing a rigorous, manualized existential talk therapy, enrolling Spanish-speaking participants, and creating for this study an enhanced, bespoke infrastructure for cross-site monitoring and regulatory compliance that will help avoid challenges that have recently befallen other psychedelic trials.
The overall PT2PC project comprises of a main trial protocol and 2 auxiliary protocols that assess the longitudinal impacts of the study on the patients, their loved ones, and the facilitators in the trial.
The project has received support from, among others, the Steven & Alexandra Cohen Foundation, the Samberg Family Foundation, the John Templeton Foundation, the Robert A. Winn Excellence in Clinical Trials Award Program, and anonymous donors.
The PT2PC project is seeking further philanthropic contributions that will allow it to maximize participant enrollment in the main protocol while also completing all the planned long-term follow-up, qualitative, and secondary quantitative analyses that complement the main protocol.
CURA is also developing future trials that will assess psychedelic therapies for other applications for which the interaction of the psyche (mind) and soma (body) are hypothesized to be critical, such as infection-associated chronic illnesses, chronic pain disorders, and functional neurological disorders.
