As the hype around psychedelics picks up pace and every week more clinical trials are announced looking at their therapeutic potential for everything from depression to anorexia, it’s easy to forget that at the centre of this research lies the trial participants putting their mental health on the line in the name of medical advancement.
Ian Roullier and Leonie Schneider, who have both taken part in clinical trials for psilocybin and met through clinical psychologist Ros Watts’ Connectedness Programme, are determined to ensure their voices and those of the growing number of trial participants feed back into the development of future psychedelic trial designs.
Nothing about me, without me
“The saying that comes to mind is ‘nothing about me, without me’,” says Roullier “because ultimately, there is no medical research into psychedelics without participants. So, arguably, we have the most important voice within the whole process.”
“There’s such a wealth of lived experience,” he explains, “that organisations can call upon to improve the treatment models they’re setting up and how they can safeguard people before, during and after the trials.”
This desire to represent the collective voice of trial participants, past, present and future, has been their motivation in setting up PsyPAN Global, a non-profit organisation created to connect and empower all psychedelic participants in clinical trials, as well as holding to account organisations involved in psychedelic research so that they maintain patients’ interests at the heart of their work.
While the antidepressant effects of Roullier’s last psilocybin trial weren’t as long-lasting as he’d hoped, this hasn’t dampened his commitment to advocating for more access to psychedelic assisted therapies.
“It’s very easy to think that the world has suddenly become very open to the idea of psychedelics,” he says referring to the countless news stories, books and documentaries currently doing the rounds. “But there’s a lot of work still to do to convince the average person that these very powerful drugs can have therapeutic, positive, medicinal effects on people and their mental health.”
Safeguarding Participants is Key
But perhaps the more pressing work for PsyPAN right now is to encourage the companies carrying out the studies to have adequate safeguarding measures in place for trial participants.
With most psychedelics research targeting treatment resistant mental health conditions, this inevitably means trial participants have endured years of uncontrolled depression and anxiety and for many, psychedelics can seem like the last hope. Which is why PsyPAN are pressing for companies to appropriately manage patients’ expectations when initially applying for the studies, fully explaining how difficult it can be to be selected for the trials in the first place.
“The sheer disappointment a lot of people experience at that point can be extremely detrimental to their mental health,” explains Roullier.
PsyPAN are also advocating that any placebo controlled studies are followed by an open label extension to ensure that all participants get to take the active dose. In some studies participants only get the placebo, which can be devastating and potentially worsen their mental health.
“I was very lucky… I did get an active dose, even though the outcome wasn’t what I’d hoped for,” says Roullier. “But you have people that have come off their antidepressants, often in quite a tight timeframe. So quite often they’ll be experiencing withdrawal and that’s really destabilising in itself. And then you have all of your hopes built up that you’re going to get this drug… one dose and your depression is gone forever.”
This lack of nuance surrounding psychedelics stirred up by a media storm painting psychedelics as a miracle cure for mental health is something PsyPAN believes is important to counter.
“We desperately need people to understand that yes, this can really help people and it can help alleviate their depression. But it’s not that silver bullet,” says Roulllier.
The Importance of Therapeutic Support
PsyPAN is also committed to pushing back against moves within the psychedelics industry to cut back on therapy and integration support in order to make psychedelic treatments more scalable.
“The psychotherapeutic element is vital,” insists Roullier, “in helping any breakthroughs to stick, to help somebody make those subtle, sustainable changes, or the huge life changing ones as well… You need support to be able to do that, to help you make sense of what you’ve experienced.”
However, for Roullier and Schneider, not all psychedelic integration is created equal and they advocate for the provision of integration groups created specifically for clinical trial participants.
“Many people go from the isolation, loneliness and the desperation of depression,” Roullier explains, “go through a psychedelic trial to help them mental health, and then come out the other end. Even if it’s been successful and even if it’s really helped them, they’re left feeling isolated and lonely because nobody in their circle really understands what they’ve experienced.”
Roullier himself remembers a sense of abandonment when he finished his first clinical trial and hopes that PsyPAN’s role will also include providing a vital sense of community and connection for the ever growing number of people taking part in psychedelics trials.
People Before Profit
But more than anything, PsyPAN, who eventually intend to create a form of accreditation for clinical trials and treatment centres, are fully conscious that now is the moment to ensure profit doesn’t get in the way of optimising participant experiences and outcomes.
“I think that’s a key reason why we need to exist… Hopefully we can help organisations to see that it’s not like any other drug; the small details make a huge difference…If you’re an organisation that’s just going to cut corners or remove all psychotherapy and replace it with an AI bot, you will naturally fail, and there’ll be others giving a greater therapeutic element within their trials that will succeed because the outcomes will be better.”
Time will tell whether the psychedelics industry truly embraces PsyPAN’s goals, or if the financial pressures of shareholders and regulators eventually force the corner-cutting measures Roullier and Schneider fear the most.
Mary Biles is a plant medicine advocate, author of The CBD Book, medical cannabis writer and podcast host who loves to unpack the science behind medicinal plants and psychedelics. Tweets @Mary_Biles