Caution, safety and research at the centre of psychedelics memo

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 emphasised the importance of a “safety first” approach in adopting this treatment to protect some of the most vulnerable people in the community.

Ahead of the regulatory change from 1 July, 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-assisted therapy may offer hope to a small number of patients where other treatments have been attempted without lasting success,” Harvey said.

“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 it’s 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 are patient safety, continued research and caution.

The Clinical Memorandum outlines:

• Current evidence for psychedelic-assisted therapy, which is drawn from research trials that feature psychotherapy as a core component of the treatment model. Psychedelic-assisted therapy is the use of a psychedelic drug as a tool to support or assist psychotherapy.
• The evidence base for psychedelic-assisted therapy with either MDMA or psilocybin is limited and emerging. Patient safety is paramount. Psychedelic-assisted therapy carries unique risks that reinforce the need for careful clinical judgement and clear communication with potential patients. The use of psychedelic-assisted therapy with either MDMA or psilocybin is only recommended for those for whom established psychiatric treatment methods have been attempted without lasting success.
• Treatment protocols must be carefully designed and led by psychiatrists with appropriate training in psychedelic-assisted therapy, including prior experience in treating at least one patient with psychedelic-assisted therapy using the same psychedelic drug for the same indication in a clinical trial or in a clinical setting; or failing this, the treating psychiatrists must be closely supervised by a psychiatrist who has prior experience with psychedelic-assisted therapy.¹
• The delivery of psychedelic-assisted therapy using either MDMA or psilocybin must occur under highly controlled conditions and include the careful monitoring and reporting of efficacy and safety outcomes. Data, including on adverse events, must be collected systematically and longitudinally.
• The prescribing psychiatrist carries overall responsibility for the course of psychedelic-assisted therapy, including patient selection, detailed assessment, obtaining informed consent, monitoring outcomes and progress of the therapy, and appropriate plans for follow-up after the completion of treatment.
• Further research is required to assess the shorter- and longer-term safety and effectiveness of psychedelic-assisted therapy using either MDMA or psilocybin.
   

^{1. When direct supervision is provided to the treating psychiatrist, this must be by a psychiatrist based in Australia or New Zealand who has prior experience in treating patients with PAT using the same psychedelic drug for the same indication in a clinical trial or in a clinical setting. The supervising psychiatrist must be named on any HREC submissions for any proposed clinical programs.}

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