Speaker Bio
Paul Liknaitzky is Head of the Clinical Psychedelic Lab at Monash University, and Chief Principal Investigator on a program of psychedelic trials. He is a Senior Research Fellow within the Dept of Psychiatry at Monash University, and has an Honours degree in Neuroscience and a PhD in Psychology from the University of Melbourne. In Australia, he is an Investigator on many of the country’s initial psychedelic trials across multiple institutions, has coordinated several psychedelic therapist training and supervision programs, and leads the first clinical psychedelic lab. His work is focused on a rigorous program of research in clinical psychedelics that seeks to innovate on treatment design, evaluate therapeutic effects, mitigate known risks, explore potential drawbacks, and understand therapeutic mechanisms.
ICPR 2024 Abstract
Psilocybin-assisted psychotherapy for Generalised Anxiety Disorder: examining the role of expectations, masking rates, and ‘placebo’ responding in a world-first randomised controlled trial
Psilocybin-assisted psychotherapy has shown promising safety and efficacy in addressing depression, substance use disorders, and end-of-life distress. While many of these trials report reductions on secondary anxiety, no trials to date have tested the utility of this treatment for a primary anxiety condition.
In this world-first, randomised triple-blind active-placebo-controlled trial, we assessed the safety and efficacy of a psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD). Seventy-two participants were randomly assigned to receive either two doses of psilocybin (25mg to 30mg) or active placebo (diphenhydramine, 75mg to 100mg) alongside 9 psychotherapy sessions. Key safety and efficacy results will be presented for the first time.
The primary efficacy measure was the difference between treatment arms in Hamilton Anxiety Ratings Scale (HAM-A) from baseline to week 11 (6-weeks following the final dosing session). Additional efficacy and secondary clinical measures included proportion of clinician-rated response and remission, self-reported anxiety, functional impairment, wellbeing, quality of life, depression, social anxiety, panic, alcohol use, illicit drug use, tobacco use, and physical symptoms. Safety was assessed as the difference between treatment arms in frequency of serious adverse events, adverse events, and suicidality from baseline through to week 11.
This presentation provides an overview of the trial's rationale, design, methodology, and key safety and efficacy outcomes. The results from this well-controlled and well-powered clinical trial contribute significantly to our understanding of the potential of psilocybin-assisted psychotherapy as a viable treatment for severe, protracted, and generalised anxiety.