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Psychedelic therapies are on the horizon, but who will administer the drugs?

Psychedelics are gaining momentum as potential therapies for certain mental health conditions and may soon be prescribed by doctors in some states. As clinical trials on psychedelics continue, and as legalization efforts gain win after win, schools are ramping up efforts to train the therapists and practitioners who will administer them.

Psychedelic therapy is nowhere near as simple as filling a prescription and taking a pill at home. Instead, administering psychedelics — such as psilocybin, the compound in “magic mushrooms,” among others — can be a daylong experience, where the patient is constantly monitored by trained practitioners. 

Janis Phelps is on the front line of training those practitioners. A clinical psychologist, she founded and now leads the first accredited psychedelic therapy training program in the U.S. at the California Institute of Integral Studies. The San Francisco university opened its doors in 1968 and offers courses in psychology, counseling, spirituality and Eastern medicine. 

The CIIS has trained roughly 800 students in the psychedelic program since 2016, Phelps said. And with receptiveness toward psychedelics growing, more practitioners are seeking out instruction. The program tripled in size after expanding to add a training site in Boston last year, she said.

Phelps estimates that at least 8,000 newly trained therapists will be needed in the next decade.

“We decided we need so many therapists trained, and there’s so few people on the planet who know how to use this effectively, that we started training people even before it was legal to use, unless you were in a research study,” Phelps said.

The psychedelic therapy program entails 150 hours of instruction and several in-person training sessions. Many students are licensed therapists, psychiatrists and physicians. Social workers, nutritionists, ordained clergy and people in other nonmedical occupations are also eligible to apply. 

Aug. 24, 202203:45

Universities including CIIS, Phelps said, teach the methods used in the clinical trials for administering psychedelics and monitoring the participants — protocols that are approved by the Food and Drug Administration.

In addition to monitoring the patients throughout their trip for any safety concerns, students are also taught to support and validate emotions that come up during the experience, rather than try to direct the patient’s experience themselves, said Dr. Anne St. Goar, a former primary care doctor who was among the first CIIS-accredited practitioners and now leads the Boston training site. Unlike in talk therapy, she said, patients are encouraged to process their thoughts in silence, while the therapist observes. When needed or requested, the therapist will take a more active role by talking with their patient, reassuring them or holding their hand with consent.

One snag, however, is that outside of approved use in clinical trials, psychedelics remain illegal at the federal level. That means that CIIS students are trained how to facilitate safe psychedelic sessions without the drugs in hand. 

In the absence of psychedelic drugs, CIIS students are taught so-called Holotropic Breathwork, a breathing exercise developed by a psychiatrist in the 1970s that, according to CIIS graduate Dr. Yvan Beaussant, a palliative care physician at Harvard’s Dana-Farber Cancer Institute, “involves music and breathing techniques as a means to induce a psychedelic-like state.” A 2018 review published in Frontiers in Human Neuroscience hypothesized that breathwork might alter the activity in the same network of the brain associated with sleep, meditation and psychedelics.

Beginning in January, CIIS graduates will be eligible to apply to practice in Oregon, the first state that has legalized supervised psilocybin sessions. Facilitators must complete an approved training program, like the one offered by CIIS, pass an exam and pay licensing fees. And licensed centers in the state will eventually serve as an experiential training ground for future students.

Oregon officials hope that the state will “demonstrate that we can do this safely and really help people with their healing and wellness — and promote more options for folks that are wanting a different option,” said Angela Allbee, the section manager of Oregon Psilocybin Services.

So why the growing interest in using psychedelic drugs for mental health?

The federal government has considered psychedelics to be drugs of abuse with “no currently accepted medical use” for half a century. But in the 1950s, psychedelics captured the attention of the medical world. Early research suggested some hallucinogens, in the right setting, could increase empathy in therapeutic work and were effective in treating a variety of intractable mental health conditions, including alcoholism. 

Studies came to a halt in the 1970s after psychedelics developed a reputation as dangerous recreational drugs. But scientists at Johns Hopkins University and New York University delved back into their medical potential in the late 2000s, launching a renaissance in psychedelic research.

By 2017, the FDA had designated MDMA — also known as ecstasy and molly — as a “breakthrough therapy” for its potential to treat post-traumatic stress disorder more effectively than existing options. Of the 12 million adults in the U.S. who have PTSD in a given year, 5 in 10 respond to talk therapy and 4 in 10 are estimated to reach remission using medication alone, according to the U.S. Department of Veterans Affairs

A clinical trial conducted by the Multidisciplinary Association for Psychedelic Studies, a nonprofit that raises money for psychedelic research, found that talk therapy with MDMA was twice as effective in treating PTSD, compared with talk therapy alone. The group finished collecting data for its second Phase 3 trial — an advanced stage of drug testing that compares it to existing treatments — in November. In 2023, MAPS is expected to submit its data to the FDA to review for possible approval. 

Several other clinical trials have found therapeutic uses for another psychedelic, psilocybin. A recent study from the NYU Langone Center for Psychedelic Medicine found two doses of psilocybin, combined with therapy, helped reduce drinking for eight months in people with alcohol use disorder. Another found that psilocybin helped cancer patients feel less distressed about their condition. A large clinical trial is set to begin by the end of month studying whether psilocybin can treat depression when other approaches have failed.

Turn on, tune in, drop out?

Treatment with psychedelic drugs is not as simple as giving the patient a pill to take at home, and it’s not for everybody. Psychedelics can induce profound visual and sensory distortions, as well as emotionally challenging experiences for patients. Harmful drug interactions can also happen when the user is taking certain medications, so patients in clinical trials are screened prior to starting. 

A half-dozen therapists with psychedelic training who spoke to NBC News said that how a trip unfolds depends largely on the “set and setting” — the mindset the patient enters the treatment with and the physical setting they are in. This is why patients lie down and dawn eye shades and headphones in a space designed to look more like a cozy den than a hospital room during the drug session.

A session with MDMA or psilocybin can last as long as eight hours, during which the patient may revisit events and emotions with the therapists’ support. In clinical trials, therapists also work with the participants for a few sessions prior to taking the drug and for several afterward to process the experience. 

The experience “strangely resonates in a very unique and meaningful way for most people,” said  Beaussant, of the Dana-Farber Cancer Institute, who is researching psilocybin to ease end-of-life distress. “Usually people are able to better communicate areas of their psyche that feel unresolved and to process trauma or grief.” 

A long trip ahead

As the largest-to-date clinical trial of psilocybin is set to begin this month, several states have attempted to relax restrictions around this substance in particular. Voters in Oregon passed a measure legalizing the supervised adult use of psilocybin in 2020. And in November, Colorado became the second state to do so. 

But much of the fine print of how and which patients will be able to access psychedelic therapy and for what conditions is to be decided by the FDA.

A May letter from the U.S. Department of Health and Human Services indicated the Biden administration is considering establishing a federal task force to address the complexities of approving psychedelic drugs. And state-issued groups in Oregon and Colorado are tasked with navigating the details of licensing, dosing and further protocols.

Kevin Franciotti, a licensed addiction counselor in Denver who is trained in the off-label use of ketamine for psychotherapy, said the increasing demand for psychedelic therapies is a double-edged sword. 

“Patients are going to be very excited about this, then suddenly very disappointed and frustrated because there may be a substantial lack of qualified practitioners outside of major cities,” he added.

Franciotti supported the psilocybin legalization measure in Colorado, telling NBC News this was the state’s chance to provide its residents with alternative treatment options and push back against existing drug policy.

With the renewed attention toward psychedelics in medicine, some mental health practitioners are questioning how drug regulations, which still make psychedelics illegal at the federal level, affect research. 

“There are a lot of psychedelics out there and nobody is researching them” because of federal restrictions, said Dr. Franklin King IV, an emergency psychiatrist and the director of training at the Center for the Neuroscience of Psychedelics at Massachusetts General Hospital. “It’s hard to study and get FDA approval for drugs with limited safety data, so the hurdles are high, even for psilocybin.” 

“Legalization is repeatedly the biggest obstacle in all research of psychedelics,” said King, who added that it can often be easier to get funding to study other psychoactive drugs that come with known harms, like opioids, than to get funding for psychedelics. “Psychedelics are not going to erase or replace all these other treatments we have, but there is a huge utility for them and a huge demand.” 

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