Interested in giving psychedelic therapy a go? It will probably look something like this: In a room of muted colors, you’ll swallow a dose of a psychedelic drug, then lie back on a futon. Gentle music will play in the background; maybe some Brian Eno. You won’t be alone: One or two therapists will be readily by your side, guiding and prompting you through a session that will last up to eight hours.
This is the model that features in the majority of the scientific research looking at the potential of psychedelic drugs, like psilocybin or MDMA, to treat mental illnesses such as depression and post-traumatic stress disorder (PTSD). In the field, it’s long been taken as fact that the skills of a trained therapist are necessary to support tripping patients, both to ensure safety and to maximize the treatment’s therapeutic potential. But a new opinion piece in JAMA Psychiatry warns that beneath the hype, the therapy component of psychedelic-assisted therapy isn’t being studied enough—and could pose a risk to patients.
One of the piece’s authors is Meaghan Buisson, who in 2015 took part in a clinical trial of MDMA-assisted therapy for PTSD run by the Multidisciplinary Association for Psychedelic Studies (MAPS), a psychedelic research nonprofit based in California. Another is Sarah McNamee, a licensed psychotherapist and academic researcher of trauma and psychotherapy at McGill University in Canada, who has also participated in a MAPS clinical trial. MAPS guidelines are some of the most commonly used in psychedelic-assisted therapy—specifically, its manual for using MDMA to treat PTSD. And herein lies the problem.
The first version of the manual was written in 2002 by psychiatrist Michael Mithoefer, MAPS’ senior medical director. It was largely inspired by the work of Stanislov Grof, a Czech-born psychiatrist, and relied heavily on Grof’s work on LSD psychotherapy from the 1970s. In fact, Grof’s work laid the foundation for much of mainstream psychedelic therapy today. But experts who spoke to WIRED argue that Grof’s principles have become accepted and promoted as classic tenets of psychedelic therapy without enough questioning.
“A lot of the ideas that are taken for granted [on] the way psychedelic-assisted therapy works are not evidence-based. They’re not ideas that are rooted in any kind of traditional scientific evidence,” says the opinion piece’s third coauthor, Neşe Devenot, a postdoctoral associate at the Institute for Research in Sensing at the University of Cincinnati. And the speed at which researchers are racing to get the therapy out to the masses means that the time to scrutinize this component is running out. “They’re building the airplane while they’re flying it,” she says.
THE IMPORTANCE OF the therapy element of psychedelic-assisted therapy has been a bone of contention in the field as far back as the 1960s, when psychedelic drugs were first being tried as medicines. Some argue that the treatment’s benefit lies directly in the therapy, and that the psychedelic drug in question simply catalyzes the therapeutic process. Others contend the hallucinogenic trip may not even be necessary to get the mental health benefits; rather, they believe these come from the drug itself.
Psychedelic-assisted therapy is not simply a form of therapy, or simply a form of medication; it’s both. And that’s what makes it so difficult to study. But while much of the focus has been on how the drugs work, far less time has been spent working out the role of psychotherapy in treatment, and what exactly that treatment should look like.
In a paper assessing trials of using MDMA to treat PTSD and psilocybin—the psychedelic substance contained in magic mushrooms—for treatment-resistant depression, the authors pointed out that there had been no evaluations of the psychotherapy component of the interventions. In the case of a MAPS Phase III MDMA trial that the paper reviewed, the patients had received bespoke therapy that was never independently evaluated.
A key part of getting psychedelic-assisted therapy approved and rolled out will be showing convincingly that it works. And that means conducting big, well-run clinical trials. Organizations like MAPS are conducting trials, but the sheer diversity of therapy being used undermines their results. In the case of the MAPS manual, therapists are expected to have experience with therapy for PTSD, but may draw on up to 13 types of therapy as they please. “Elements of each of these psychotherapeutic approaches may occur spontaneously in MDMA-assisted therapy,” the manual reads.
“It’s crazy, all the heterogeneity of what folks were trained in,” says Eiko Fried, associate professor of psychology at the University of Leiden in the Netherlands. (According to New York magazine’s investigative podcast, Cover Story: Power Trip, MAPS’ chief of therapy training and supervision was reportedly unfamiliar that such spontaneity was allowed.) “It’s not normal in a treatment study to say, do whatever psychotherapy you want, for whatever length you want,” says Fried. Such inconsistencies inevitably muddle the results, meaning “you can’t really learn much. You’re shooting yourself in the foot with protocols like that.”
Gillender Bedi, a clinical psychologist and senior research fellow at mental health nonprofit Orygen and the University of Melbourne, was gearing up to run her own clinical trial to investigate MDMA-assisted psychotherapy. Bedi asked a colleague who works in the trauma field to take a look at the MAPS manual. “She was like, this is not even recognizable as therapy. This is not anything like what we would be doing for trauma,” Bedi says.
There’s also little evidence to back up how necessary or helpful many of the accepted norms in psychedelic-assisted therapy are—and some could even be potentially harmful. One of the more problematic is the concept of “nurturing touch,” which can take the form of hand-holding and hugging. Another encouraged form of touch is “focused bodywork,” in which the therapist offers their body as a form of resistance the patient can push against. In traditional psychotherapy, touching a patient is considered controversial—both therapists and patients have differing views on whether it is appropriate.
The MAPS manual advises that “mindful use of touch can be an important catalyst to healing.” It elaborates: “Nurturing touch that occurs when the participant is deeply re-connecting with times in life when they needed and did not get it can provide an important corrective experience.” The evidence to support this claim is not provided.
On touches of a sexual nature, it reads: “Any touch that has sexual connotations or is driven by the therapist’s needs, rather than the participant’s, has no place in therapy and can be counter-therapeutic or even abusive.” But the lack of further description leaves it up to the therapist to interpret the connotations of a touch and whose needs it is serving, Devenot says.
The manual advises that the therapist obtain the individual’s consent before touching them, but whether a patient can give consent in an altered state of consciousness is a point of concern, says Bedi—especially if they’re under the influence of a drug known to enhance suggestibility and sexual feelings. “The idea that people have the capacity to consent when they’re essentially really intoxicated [is] just something that we wouldn’t accept in any other setting,” Bedi says.
McNamee, whose interest in psychedelic therapy led her to seek out training and join communities of clinicians who work with psychedelics, says that she has witnessed insiders “discuss the merits of cuddling clients” in order to repair “wounds of childhood neglect.”
Another commonly used approach involves conducting sessions with two therapists instead of one, generally one female and one male. Sometimes, these therapists are married, as was the case for Meaghan Buisson during her 2015 MAPS clinical trial. MAPS requires only one therapist in its trials to have a license, which, executive director Rick Doblin says, is to reduce costs for patients. This was also the case in Buisson’s situation.
If that unlicensed therapist causes harm, there’s no regulatory board to hold them accountable. Such a scenario is alleged to have happened with Buisson and one of her therapists, Richard Yensen. After active treatment in the 2015 trial had ended, Buisson continued to see the two therapists. During this period, she alleges that Yensen sexually assaulted her.
In response to a civil claim Buisson brought against him, Yensen said that he had entered into a consensual intimate relationship with her. The claim was settled out of court. Buisson later lodged a sexual assault complaint against Yensen with the police over the same events, and the police recommended charges, but the complaint wasn’t pursued by the prosecution services. Neither Yensen nor his co-therapist, Donna Dryer, responded to requests for comment.
MAPS has since barred Yensen and Dryer; Dryer is still a practicing psychiatrist. “The situation with the MAPS trial really highlights the dangers of not having licensed people in the situation, because there is no recourse to regulatory oversight if someone is not licensed,” says Bedi. MAPS did not offer a comment on Buisson’s alleged assault or on its clinical trial guidance.
The reasoning for co-therapists, as well as how co-therapy should function, is not elaborated on in the MAPS manual. In reality, the concept of a male and female therapist duo in psychedelic therapy was adopted to try to prevent sexual abuse in the wake of reports that Richard Ingrasci, a psychiatrist using MDMA in his practice, had sexually abused his patients in the late 1980s.
Finally, while the importance of “set and setting” in psychedelic therapy is widely accepted—that the participant’s expectations and intentions going in, as well as the environment in which they’re receiving the therapy, has a big influence on the experience—exactly what the right mindset and setting are hasn’t really been researched, says Amy McGuire, a biomedical ethicist at Baylor College of Medicine in Texas.
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.
Updated 4-6-2023 14.30 pm BST: The details of Richard Yensen’s response to Meaghan Buisson’s civil claim were clarified. A clarification that the police recommended charges over Buisson’s complaint was also added.