Incannex Healthcare, in partnership with Monash University, has obtained ethics approval to begin the first-ever clinical trial investigating the effects of psilocybin assisted psychotherapy to treat generalised anxiety disorder (GAD).
Psilocybin, commonly known as the active ingredient in magic mushrooms, are one of the more popular naturally occurring psychedelics that are consumed for hallucinogenic effects.
Late last week, the Monash University Human Research Ethics Committee (MUHREC) greenlit the second-phase clinical trial to treat GAD with a combination of psilocybin and specialised therapy as psychedelics trigger changes in perception, mood and thought.
Incannex Healthcare is a clinical-stage pharmaceutical company that has mainly focussed on the development of medicines using cannabinoids and psychedelic compounds. Since the second phase of the clinical trial was announced, shares in Incannex Healthcare are up 7.41% and trading at 0.44AUD each.
The use of psychedelic compounds in medicine is a growing interest to the public, with previous studies showing effective treatment of symptoms for PTSD, depression, anxiety, and social disconnection.
Monash University are looking to recruit 72 participants in this trial, making it the largest psychedelic research and development programme in Australia.
Thrilled to announce we’ve received ethics approval for the world’s first trial investigating psilocybin-assisted psychotherapy to treat Generalised Anxiety Disorder! (1/n) pic.twitter.com/ii3TmQU747
— Paul Liknaitzky, PhD (@PLiknaitzky) October 27, 2021
Generalised Anxiety Disorder symptoms can include constant worry, restlessness, and trouble with concentration. GAD affects nearly six percent of Australians that we know of, and current treatments often provide inadequate outcomes and problematic side effects.
Evidence is being gathered to show that psychotherapy assisted by psilocybin can be incredibly useful. The effects of which are often reported to be remarkable, moving, beneficial, and difficult to describe.
From what we know so far, clinical support is an integral part of this treatment. In order to have effective outcomes, empathic therapists with specialist training are essential. This also incorporates a world-first option for trial therapists to receive psilocybin under supportive conditions.
While taking magic mushies with your psych sounds like a bit of a trip (pardon the pun), Head of Clinical Psychedelic Research at Monash University, Dr Liknaitzky says:
“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.”
This trial, led by the Clinic Psychedelic Research Lab within the Department of Psychiatry and the Turner Institute for Brain and Mental Health will be held at Monash University and is set to start patient recruitment early next year.
“Given the early yet highly promising results from other psilocybin trials for different conditions,” says Dr Liknaitzky, “this treatment – alongside innovations we’ve developed – may deliver a substantial step forward in the treatment of anxiety disorders.”