Her concern is that the dearth of data surrounding the psychotherapy component of psychedelic-assisted therapy results in a lack of best practices, guidelines, and regulation around it. “We won’t know what those should look like until we have a better sense of what’s currently being done, and what works and what doesn’t work,” McGuire says. “At this point, I don’t even think we know enough to know what role psychotherapy has in the whole therapeutic process at all,” she says. 

McNamee’s concern is that the psychotherapy component is often lauded as an important safety measure for public and regulatory agencies, who may be skittish about giving these drugs to vulnerable patients. “But in reality, the therapies that accompany the drugs are a mixed bag of controversial methods, spiritual beliefs, therapeutic misconceptions, and large gaps that can be filled with whatever prior values, beliefs, and experiences therapists bring with them into those sessions.”

So what would better research look like? From a clinical trial perspective, Fried says that protocols need to be reasonably homogenous enough for researchers to learn what the working mechanism is. They should use psychotherapy methods that have a sturdier evidence base, such as cognitive-behavioral therapy (CBT). And researchers need to be more open in sharing what protocols they’re using, says McGuire. Bedi points out that since many of the currently used methods are based on work from the 1970s, they fail to account for the changes that have occurred in psychotherapy in the past 50 years.

That’s not to say there has been no research investigating different aspects of the therapy: One study looked at the effects of different music genres in the setting, in a trial that involved psilocybin to treat smoking addiction. But in general, “we’re not collecting the data that we would need to advance the debate,” says Devenot. “And that, to me, [is] the core issue.” 

Time to gather this data is running out. MDMA could be approved by the US Food and Drug Administration (FDA) for the treatment of PTSD as early as 2024, and Australia recently announced it would allow MDMA and psilocybin to be used in a therapeutic context from July 2023.

In Australia, the Therapeutic Goods Administration (TGA)—the government authority responsible for regulating medicines and approving the rescheduling of psychedelics—will approve therapists’ processes on a case-by-case basis. But at the moment, the only body offering training for the therapy component is Mind Medicine Australia, an advocacy group for psychedelic medicine. This training is not yet recognized by the necessary authorities, so what exactly the training should look like is something they will have to figure out by June. “Australia is going to be a really important jurisdiction for us to be looking toward, to see what some of the challenges are,” says McGuire.

Another testing ground is Oregon. At the beginning of this year, it became the first state to legalize the manufacture and administration of psilocybin, but only under the supervision of a facilitator. Facilitators must complete 160 hours of training and 40 hours of hands-on experience to be licensed. They are not required to have any experience in mental health treatment—only a high school diploma, a background check, and an Oregon residency. Under Oregon’s regulations, facilitators are allowed to touch the hands and shoulders of their patients only with prior written consent. Importantly, Oregon’s rollout doesn’t require facilitators to offer psychotherapeutic support; rather, they will prepare the patient, provide supervision during the session, and help with integration afterward. Whether this counts as therapy remains up for debate. 

McNamee doesn’t doubt that psychedelic-assisted therapies will help people, and has benefited from them herself. “But if these treatments are approved and scaled up as they currently are formulated, based on inadequate safety and efficacy data, people are going to be harmed,” she says.