Monash University has received ethics approval for a clinical trial investigating psilocybin-assisted psychotherapy to treat severe Generalised Anxiety Disorder (GAD), with therapists given the option of taking the drug themselves.
The partnership with Incannex Healthcare will see a randomised triple-blinded active-placebo-controlled trial led by Monash head of clinical psychedelic research Dr Paul Liknaitzky. It will assess the safety and efficacy of psilocybin-assisted psychotherapy and explore how the treatment works.
Monash is looking to recruit 72 participants for the trial, which will include psilocybin sessions alongside a program of specialised psychotherapy from qualified mental healthcare workers. Therapists working on the trial are currently undergoing extensive training that will incorporate an option to receive psilocybin under supportive conditions.
Dr Liknaitzky said: “Previous research suggests that psychedelic therapist training can be substantially enhanced if therapists can experience well-supported psychedelic effects, becoming better equipped to accompany clinical participants through profoundly unfamiliar terrain.
“That is why we will provide the option to our research therapists to undergo supported psilocybin sessions as part of their training, a process that is likely to improve outcomes for our clinical participants.”
The impact of this aspect of the training will be scientifically investigated from the perspectives of both therapist and clinical participant. Trial therapists will also work under supervision from international psychedelic experts for its duration.
Lead psychedelic trainer and therapist at Monash Sean O’Carroll said: “As psychotherapists, we regularly witness the psychological pain and suffering inflicted by severe GAD, a condition which is notoriously difficult to treat. It is increasingly clear that psychedelics — when used in conjunction with intensive and novel psychotherapeutic interventions — have great healing potential.
“This trial will provide us with an opportunity to make a real contribution to the field, by deepening our understanding of how to best work with these powerful substances. It’s very exciting.”
Meanwhile, Incannex has received positive feedback from the US Food and Drug Administration (FDA) following the submission of its pre-investigational new drug application.
The FDA confirmed “the therapeutic strategy for the development of a psilocybin-assisted therapy for GAD is appropriate”, and conveyed interest in its development.
GAD involves intense anxiety and worry most of the time and can be so excessive that everyday life becomes difficult. Experienced by more women than men, nearly 6% of the Australian population will experience GAD in their lifetime.