Grant: Project Grant

Over 2.5 million Canadians suffer from posttraumatic stress disorder (PTSD), creating a significant burden. Current front-line treatments, such as intensive cognitive processing therapy (ICPT), which is delivered in multiple sessions over 7 days, are ineffective for up to half of affected Canadians. However, rather than seeking entirely new treatments, ICPT efficacy may be enhanced through adjunctive approaches. One promising strategy is the use of psilocybin, a naturally occurring compound that enhances the brain's ability to "rewire itself." Preliminary evidence suggests that psilocybin may help alleviate PTSD symptoms. However, the tolerability, safety, and potential efficacy of psilocybin-assisted ICPT (Pa-ICPT) for chronic PTSD remain unknown. To address this knowledge gap, we propose a multi-site, pilot randomized controlled trial (RCT). Eighty diverse adults with chronic PTSD will be recruited in Toronto, Ottawa, London, and Edmonton. Participants will be randomly assigned to receive a single dose of psilocybin 25 mg or niacin 250 mg, combined with 12 ICPT sessions and 2 psilocybin-related psychotherapy sessions over 7 days. This study will assess the feasibility of the trial design, the tolerability and safety of the interventions, and changes in clinical outcomes. Using a combination of quantitative and qualitative measures, this research will inform the design of a large, definitive multi-site RCT to evaluate the efficacy of Pa-ICPT for chronic PTSD. This is the first trial worldwide to combine ICPT with psilocybin for PTSD treatment, setting the stage for further research on Pa-ICPT for other psychiatric conditions while paving the way for future regulatory approval. Ultimately, this research will provide a faster, more personalized, and effective treatment for Canadians struggling with PTSD and beyond, contributing to the advancement of innovative therapeutic approaches.