The Promise & Peril Of Psychedelic-Assisted Therapy

Every so often, the mbg Slack news channel becomes a hive of activity, set off by a discovery we know will be a game-changer in the well-being space. When our co-CEO Jason Wachob sent through this JAMA1 psilocybin for depression research1 in November was one of those times.

The study explored how psilocybin, the natural active psychedelic in magic mushrooms, affected people with depression when administered in a therapeutic setting. Researchers out of the Center for Psychedelic and Consciousness Research at Johns Hopkins Bayview Medical Center administered the drug to 24 adults over the course of two randomized, controlled trials. The first group received it right away, while the other group had delayed treatment.

Compared to the control group, the group that first received the psilocybin had significantly lower depression scores based on blinded clinician raters using the GRID-Hamilton Depression Rating Scale. This improvement began immediately and stuck around for the four-week follow-up in 71% of participants. In other words, it worked.

This wasn't the only study to explore a new type of mental health intervention this year. Multidisciplinary Association of Psychedelic Studies (MAPS) is also in the midst of Stage 3 trials on how MDMA—another schedule 1 drug that has psychedelic properties—could be used in conjunction with therapy to help those suffering from PTSD. In Stage 2 trials,2 published in 2019, two to three eight-hour sessions of MDMA-assisted psychotherapy sessions effectively reduced PTSD symptoms in the majority of participants, with benefits extending at least 12 months after the treatment. 

Rooted in sound scientific practice and published in major peer-reviewed journals, this research shows that psychedelics—most of which were made illegal schedule 1 drugs in the mid 20th century—might soon have a role to play in Western medicine.

Supported by crowd-sourced funding3, the psilocybin study was released in the same month that Oregon residents voted to legalize psilocybin for therapeutic use, setting off the process of looking into how it could be administered and regulated within state lines. Clearly, there is a base of support for taking these drugs out of the hushed party scene and into more mainstream healing spaces.

You won't see MDMA and psilocybin offered at your local clinic any time soon. More research on larger, more diverse populations who undergo longer-term follow-up is needed. It's in progress but won't wrap up until at least 2022–2023, at which point the Food & Drug Administration (FDA) will look into whether to approve these treatments.

The FDA has already voiced confidence in two psilocybin programs (out of COMPASS Pathways and Usona Institute) by granting them "breakthrough" therapy status for treatment-resistant depression. This means that if enough solid evidence comes in for the treatment, the FDA will fast-track its review process. The FDA has given the same designation to MAPS for its work on MDMA-assisted psychotherapy for PTSD.

As results from these trials continue to trickle in the coming years, expect more conversations about how these drugs should eventually be administered and to whom.

It's a controversial topic that mbg first started covering in a major way last year. At revitalize 2019, one panel was focused on whether psychedelics have a place in wellness. Panelists were divided but agreed that if these medicines do become medically legal, they need to be administered in a controlled, safe setting and cannot be presented as miracle drugs.

One of the speakers, Stanford lecturer Molly Maloof, M.D., expanded on this idea when she visited the mbg podcast. "We need to build systems that enable clinicians and therapists to work together to deliver these extensive lifestyle programs," she said.

In other words, these drugs don't act in isolation. They seem to help people break down barriers to their subconscious and face pain and trauma, but trained therapists need to be there to guide this process.

Marcela Ot'alora, MFA, M.A., LPC, a psychotherapist and the principal investigator for the MAPS MDMA-assisted trials, tells mbg that in the ongoing Phase 3 trials, participants and therapists spend three 90-minute sessions preparing and getting to know each other before the eight-hour session with MDMA. Following that session, they then meet in person three more times to unpack the experience further as well as connect on the phone. It's not a quick treatment plan.

"It's about 42 hours of therapy," Ot'alora tells mbg, explaining that her team believes that in MDMA-assisted psychotherapy, the therapist's involvement is just as essential as the drug. Therapists are the ones responsible for setting up a safe and secure container for the experience and helping patients translate it to day-to-day life.

The therapy component of the psilocybin for depression study was also substantial: Before the session, therapists spent eight hours developing trust with participants and equipping them with skills for navigating the experience. They also met for three hours after the initial session. "The therapy after the session is spent talking about how [participants] are going to move forward—what they are going to do differently or what they want to change," Alan K Davis, Ph.D., a researcher on the Hopkins study, tells mbg.

"Our philosophy is that you can have a psychedelic experience that's pretty powerful, but if there's no way for you to integrate it, then it just kind of gets lost," Ot'alora at MAPs says.

This shows that even when administered by trained professionals in a safe setting, these drugs do not act as a panacea. They need to be followed up with consistent self-inquiry and reflection. They are also not for everyone: People need to undergo extensive medical and psychological screening before taking them.

"The safety element is huge because there are risks with some of the more intense treatments," Gita Vaid, M.D., another psychiatrist trained in psychedelic-assisted therapy, said on the mbg podcast. "If maybe you're not as familiar as you should be with your genes, or you don't have the best medical practitioner at your side, you can do some damage."

If those criteria are met and the right person links up with the right therapist and is administered the right drug in the right setting, holistic psychiatrist Ellen Vora, M.D., said on the revitalize stage that "It's pretty reliable you're going to have a peak spiritual life experience."

If you follow the money trail supporting the research of psychedelics for mental health, you'll likely end up in New York or San Fransisco. A group of Silicon Valley and Wall Street executives raised the $30 million needed to fund the MAPS MDMA trials, with famed biohackers like Tim Ferriss rising as figureheads and funders in the journey toward legalization.

If initial funding is any indication, once legalized, there will be money to be made in these drugs, and many companies will want to vie for a slice of the proverbial pie.

"There's obviously a huge for-profit space that's going to emerge—it's already emerging," says Davis. Startups like Ember Health and Mindbloom in NYC and Field Trip Health in NYC, LA, and Chicago, have arisen as a new type of therapist's office that administers low doses of ketamine as an adjunct treatment for depression and anxiety—one that costs a pretty penny and is not typically covered by insurance.

"It's just going to continue to expand and grow—it will be, I'm sure, a multibillion-dollar business once all is said and done," Davis adds of the psychedelic space. "That's important because it means people will have access. But the problem is there are a lot of people who won't be able to afford it."

Looking forward to the future of psychedelic-assisted therapy, there are some folks looking to help make these substances, if approved, available to those who could benefit from them the most but may not live on the coast or have the cash to shell out.

Davis says he knows of conversations happening within the insurance industry about what coverage could look like. There are also groups working to make psychedelic training programs more affordable for therapists interested in working with the modality. And on the clinical side, Davis is beginning to research how historically marginalized communities—veterans with severe PTSD, Spanish-speaking individuals, and people of color who have experienced racial trauma—could uniquely benefit from these therapies. "Those subgroups have been underrepresented in most science in general," he says. "They've also been underrepresented in psychedelic clinical research."

Psychedelics could have a bright future. But as is the case with so many "new" health treatments, this one also has a rich past that shouldn't be forgotten. Indigenous people have been working with psychedelics (albeit plants instead of manufactured substances) to induce non-ordinary states for generations, and there is a lot we could learn from them.

In the MAPS research, Ot'alora says that she and her team are trying to tie indigenous knowledge and ritual into the studies as much as possible. "How do you make this space sacred for the session that is about to happen?" is one question she asks before every intervention, and with participants' permission, she'll often bring in flowers, candles, and soothing lighting to set the scene. This reverence for the power and history of psychedelic experience is something she hopes to see continue if and when these substances are made legal.

Evgenia Fotiou, Ph.D., an assistant professor of anthropology at Kent State University who completed her doctoral research on ayahuasca use in the context of tourism, also sees opportunities for a crosscultural approach to psychedelic use. She believes that a more interdisciplinary scientific framework—one that incorporates indigenous knowledge systems—would ultimately be the most healing.

"The scientific method is about asking questions and learning and revising; it's not about being set in one way of doing things," Fotiou says. "We need to start with humility," and, as she puts it, "treat people as the experts in their own reality."

COVID-19 has exacerbated the mental health crisis in America, and experts are predicting that the world will continue to grapple with these challenges long after the pandemic is behind us. In times of crisis, the more options that exist to help people navigate difficult realities, the better—as long as they are administered in a way that is equitable, transparent, sacred, and, above all else, safe.