Safety and Mechanisms of Psilocybin Therapy in Older Adults
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PROJECT SUMMARY/ABSTRACT Psilocybin Therapy (PT) has demonstrated safety and preliminary efficacy for difficult-to-treat conditions such as chronic pain and depression which are prevalent in older adults (OAs). PT couples psilocybin (a serotonin receptor agonist) with psychotherapeutic support. PT stands to potentially benefit millions of older adults (OAs) with pain, mental illness, and loneliness. Population-based studies of community psilocybin use reveal >6% of adults report persisting adverse events (AEs). OAs metabolize medicines differently compared to younger adults and may have differing prevalence, severity, and types of PT-related AEs; however, this has never been described. The lack of any safety data puts OAs in danger of harm and necessitates safety trials and observational studies to safety apply PT the meet the unique needs of OAs. To address this knowledge gap, I led a proof-of-concept pilot study of PT in palliative care patients (N=10, three OAs) which demonstrated safety, feasibility, and acceptability. The three OAs in my study, however, had 23 adverse events (AEs), many of which were likely attributable to psilocybin (e.g. nausea, anxiety, headache). Given the frequency and variety of AEs among OAs in my pilot trial, as well as favorable outcomes in my pilot, my next critical step to advance the safe and effective delivery of PT in OAs is to focus specifically on OAs. As a physician-investigator with clinical training in palliative medicine and experience conducting PT trials, I am ideally positioned to conduct this research. Yet, I lack essential skills and expertise to become a leader in the science of medication-assisted therapies in OAs, including: (1) clinical trials with a focus on phase 1 trials and PK/PD, (2) quantitative methods relevant to PT trials and mixed methods, (3) geriatric medicine to understand the unique care needs of OAs, (4) practitioner training in PT, and (5) scientific leadership and grant writing. Following a robust training plan supported by a nationally renowned team of experts and responding to NIA research priorities, I will pursue three Specific Aims. In Aim 1, I will evaluate the safety of psilocybin in OA in a phase 1 clinical trial in which I will evaluate acute PK/PD and cardiovascular effects and physical and psychological AEs over six months (N=30, age-stratified healthy OAs: 65-75, 76-80, >80). In Aim 2, I will use mixed methods to identify barriers, facilitators, and care preferences for PT in OAs. In Aim 3, I will conduct a longitudinal observational study to evaluate the safety and mechanisms of psilocybin use in OAs outside of clinical trials. Bolstered by newly acquired skills, if I identify a safe dose range of psilocybin on OAs, I will develop R-level phase 2 trials targeting pain and depression in OAs. The proposed project is the essential next step toward my long-term career goal of advancing the science of medication-assisted therapies in older and seriously ill adults.
