Today, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) released  the first of a series of guidance documents for psychiatrists treating people with PTSD and treatment resistant depression using psychedelic-assisted therapy. The College emphasized the importance of a “safety first” approach in adopting this treatment to protect some of our most vulnerable people in our community. 

Ahead of the regulatory change from July 1, Prof Richard Harvey, Chair of the RANZCP’s Psychedelic-Assisted Therapy Steering Group commented that in an experimental and emerging field, the approach must be cautious, considered and informed by the best available evidence at every turn, including within public messaging. 

“There is some compelling research, the evidence is growing, and psychedelic-asisted therapy may offer hope to a small number of patients where other treatments have been attempted without lasting success,” said Prof Harvey.  

“But psychedelic-assisted therapy is not a miracle cure that promises rapid recovery. People, and potentially very vulnerable people, can understandably feel distressed or let down if their experience does not match their expectations of this therapy. 

“There is potential for psychedelic substances to cause fear, panic and re-traumatisation. Without careful clinical judgement and clear communication with people seeking treatment, there are risks.

“To give informed consent, patients must be given a very clear understanding of the latent risks, and potentially limited benefits of psychedelic-assisted therapy for their circumstances. The outcomes of treatment with psychedelic-assisted therapy are not guaranteed.”

The RANZCP has also emphasised the need for continued research to assess the shorter and longer term safety and effectiveness of psychedelic-assisted therapy using either MDMA or psilocybin.

“Put simply, psychedelic-assisted therapy is in its infancy. There is more we need to know, and its paramount that treatment only occur in highly supportive and structured environments, comparable to what you’d see in a clinical trial setting.

“It remains unclear how much of the therapeutic effect results from the inclusion of the psychedelic substance in the therapy, and how much is derived from the psychotherapy itself and other psychological support surrounding the treatment.

Internationally, there are a handful of places where psychedelic-assisted therapies have been approved for very limited use outside of clinical trials. Australia is the first jurisdiction to have altered the way these are formally classified at a national level. 

In response to the change in classification, the Royal Australian and New Zealand College of Psychiatrists established a Psychedelic-Assisted Therapy Steering Group to develop guidance for psychiatrists in relation to the rescheduling, including advice for psychiatrists who may wish to become TGA Authorised Prescribers. At the centre of the clinical memorandum is patient safety, continued research, and caution.