The first-ever Professional Practice Guidelines for psychedelic therapy in the US have been published by the American Psychedelic Practitioners Association (APPA) and BrainFutures.
APPA and BrainFutures have established the guidelines with the aim of setting a benchmark for practitioners in psychedelic therapy.
With increasing clinical research showing positive results from psychedelic therapies as treatments for conditions such as post-traumatic stress disorder (PTSD) and treatment-resistant depression, such guidelines are vital if these therapies are to gain regulatory approval.
The guidelines have been written by a working group of experts from multiple disciplines, and have been informed by more than two dozen members of APPA, who contributed perspectives on justice, equity, diversity, and inclusion; the real-world practice of psychedelic-assisted therapy; and psychedelic use in indigenous and other settings.
“These are the most important first steps because they now set up the context for clinicians to use these particular compounds and medicines in a therapeutic way,” APPA Executive Director, Stephen Xenakis, told Psychedelic Health.
The guidelines cover topics such as consent, ethics, patient screening, preparation and safety, integration and more.
“We were able to convene well over a year, experts who had been clinicians, researchers, consultants and advisors in the field, to pull from them the best ideas of what they knew about these practices,” added Xenakis.
“Also what they knew that had been used historically. These medicines have been around for many, many decades, and the concepts that really shape how you do the practice, have probably been around since the late 19th century. To some people who are much better scholars, they’ve been around for 1000s of years.
“So there’s a long history of practice with these compounds, and the therapy, the healing that goes with them.”
Advancing innovative mental healthcare
According to the CDC, more than one in five US live with a mental illness, with young adults aged 18 to 25 years having the highest prevalence according to the National Institute of Mental Health.
Xenakis highlights that, for decades, the medical system has been disease centred, where a person is given a diagnosis which is specifically treated.
“That really was very useful – it did offer all of these years that particularly as we’ve developed new drugs and treatments, that’s been helpful,” said Xenakis. “But in fact, we now know that when it comes to mental health and brain conditions, there’s much more to those patients – the whole is much more than the sum of the parts.
“The ideas that are talked about our patient-centred care, what does the patient really come with? And what does the patient need? And how do you do set and setting and you use the drugs as the means to open up what is most important in the therapy in the interaction of the traders, the healers? And the patients? So that’s a big fundamental concept here, and most important, because it’s a game changer.”
Regulatory approval
The FDA approval of psychedelic-assisted therapies using MDMA and psilocybin has been anticipated for 2024, but to ensure the rollout, clinical practice, ethical and billing guidelines are essential.
In lieu of any potential approvals, APPA agreed this consensus-based guideline development is necessary to speed the adoption of psychedelic treatments into the US healthcare system and ensure access for all who could benefit.
“It’s very important for our governmental agencies and our payers as well. So they know that this is a more standardised way of treatment,” said Xenakis.
“It’s not just something that’s happened in a community over years in a way that’s been more free-range, but now it’s really formalised. So, it’s vitally important that we start with these professional practice guidelines.
“The governmental agencies can be reassured that very thoughtful, professional practitioners are looking at providing these treatments in a very methodical way. That – I think – can accelerate making them available to the people who need it.
“Access and equity are very, very important. We not only want to make sure that we’re doing the right thing that’s fundamental here – do no harm – but that the people that need this therapy are getting it.
“We have in this country, and also occurs in Europe, a mental health crisis. We have too many suicides. We have too many opioid overdoses. We have huge consequences and ripple effects of COVID and loneliness, and people are finding that their health and mental health is interfering with their work, with being able to enjoy their lives, with their relationships with their families.
“It’s vitally important for us to make these treatments and therapies accessible across the country and not only to people who can pay.
“This is a game changer. We’re at an inflection point, not only in our societies, and perhaps in our politics, but also health care, and now we’re bringing a particular capability at this time that can shift things significantly.”
The guidelines will be subject to change in the coming years as more research and real-world data become available, expiring two years from the date of publication.
APPA says the next steps will be to develop clinical practice guidelines, accreditation standards and ethical guidelines by 2024.
