After years of regulatory hurdles and societal stigma, psychedelic-assisted treatment for behavioral health conditions is coming into the spotlight.
The growing popularity of psychedelics is due, in part, to promising research results and multiple states relaxing regulations. Now, 2023 could be a banner year for the treatment. Psychedelic legalization is going into effect in the first state in the nation, all while approval from the U.S. Food and Drug Administration (FDA) could be in the works.
“We see [acceptance] happening both on the political and regulatory levels, as well as on a grassroots level,” Ronan Levy, co-founder and CEO of Field Trip Health & Wellness, told Behavioral Health Business.
Field Trip is a psychedelic-assisted therapy provider in North America. In the U.S., Field Trip Health operates in New York City, Chicago, Atlanta, Seattle, Washington, D.C., Los Angeles, San Diego and Houston. The provider uses a blend of ketamine, therapy and wellness support to help patients access services in their home or in an office.
Increasingly, psychedelics – including ketamine, LSD, MDMA and psilocybin – are used to treat behavioral health conditions, such as post-traumatic stress disorder (PTSD), alcohol use disorder (AUD) and depression.
State regulation moving the dial
Several states have begun efforts to legalize the use of psychedelics. In 2020, Oregon became the first state to vote to legalize the personal use of psilocybin, a “hallucinogenic chemical” that comes from certain types of mushrooms. Under its law, individuals 21 and over can receive psilocybin at service centers when a licensed facilitator is present. The law went into effect in January.
“This year will show us a significant amount about what is working there, what isn’t, and what changes are needed to improve both the quality and accessibility to the program,” Dr. Lynn-Marie Morski, medical director at Nue Life, told BHB. “It will also be very interesting to see what repercussions this has on other states.”
Nue Life is a virtual provider that offers in-home ketamine treatment.
Oregon’s legislation does not require individuals to have any diagnosis before using psychedelics. The legalization of psychedelics isn’t necessarily for mental health conditions, but the two are frequently linked.
“Instead of working on inclusion criteria, they work on exclusion criteria, meaning that everyone of a certain age can participate unless you have severe bipolar [disorder] or schizophrenia, or any of those clear counter-indications,” Levy said. “It’s a very smart approach because you can really limit the downside by ensuring you know where and how psychedelics are accessed.”
Other states have started to follow Oregon’s lead. Last year, the state of Colorado voted to legalize the supervised use of psychedelic plants and fungi for adults 18 and older. It will also create a Natural Medicine Advisory Board, which will recommend how psychedelics are regulated in Colorado. The new legislation will go into effect in 2024.
“The Oregon model will be one that people use to either emulate very closely or to alter in a certain way to work better for their state or to improve upon any areas of challenge that are revealed through the implementation of the Oregon program,” Morski said. “This is the first attempt at this. Recently, voters in Colorado passed a measure that’s similar to the one passed in Oregon but which differs in a few key areas. And I think every state will likely alter the Oregon model in some way. But I think every state that does will be learning a lot from what Oregon does this year.”
New Hampshire and California lawmakers have also proposed new legislation to legalize psychedelics for adults.
While most psychedelics are still classified as Schedule 1 drugs, which means they are intended for research use only, ketamine is a Schedule 3 drug and can be used in specific clinical settings. In 2019, the FDA approved Spravato, a nasal esketamine spray for adults with treatment-resistant depression and other depressive symptoms.
During the COVID-19 public health emergency (PHE), the federal government relaxed controlled substance regulations, enabling licensed clinicians to prescribe ketamine remotely. This opened up opportunities for more in-home and virtual care providers.
Emerging research
New research on psychedelic-assisted treatment has demonstrated positive results. JAMA published a study in August that found when patients with alcohol use disorder (AUD) had psilocybin-assisted treatment, their percentage of heavy drinking days was lowered significantly.
“We have great outcomes on clinical trials, which just validate everything that we saw in some of the academic trials over the last 10 years or so,” Levy said.
The industry is also closely watching the Multidisciplinary Association for Psychedelic Studies’ (MAPS) research on psychedelics treatment for PTSD. In 2022, MAPS completed its second Phase 3 trial on MDMA to support the substance’s FDA approval. The organization projects that MDMA-assisted therapy will receive FDA evaluation in 2023. MAPS currently has an FDA breakthrough designation for its therapy.
In MAPS’ first Phase 3 study of MDMA, researchers found that 88% of participants with severe PTSD taking MDMA significantly reduced their symptoms, compared to 60% of placebo patients.
Some industry insiders see this as the research that will lead to the first FDA clearance.
“I think you’re going to start to see MAPS potentially go first with its MDMA program for post-traumatic stress disorder,” Greg Mayes, president and CEO of Reunion Neuroscience, told BHB. “I think all expectations are that the product could be on the market and available in very late 2023, or very early 2024. But that’s going to be an important first mover.”
Reunion Neuroscience is a biopharmaceutical company focused on developing therapeutics for mental health conditions. Its lead asset is a novel psychedelic compound that treats postpartum depression and other mental health conditions.
An FDA approval could clear the way for other psychedelic-assisted treatments coming down the pipeline.
More areas of treatment in the future
As research and regulatory changes bring psychedelic-assisted treatment to the forefront, many providers and companies are exploring condition-specific treatment areas in the future.
“A week does not pass where somebody does not send me an idea for exploring the use of psychedelics in some type of mental health condition, addiction,” Mayes said. “I think there remains a very wide field out there for exploration and where these novel molecules can work.”
Mayes’ company, for example, is beginning research on indications for small patient populations. Specifically, Reunion will be researching psychedelics for treating postpartum depression in 2023.
“It’s a smaller market size; it’s a smaller patient population,” Mayes said. “It can result in smaller trials, quicker ability to develop compelling phase two data, and will ultimately cost us, our investors, and payers less money to develop a product in a smaller, niche indication.”
Field Trip is also looking to expand its scope of care beyond depression and anxiety through research and partnerships.
“There’s interest in terms of dealing with end-of-life distress and palliative care. We see it going into eating disorders and anorexia,” Levy said. “In fact, we are going to, at some point, host a trial at Field Trip in partnership with MAPS looking at MDMA-assisted therapy for the treatment of eating disorders.”
The industry may also be moving into the digital space. Companies like Field Trip and Nue Life both have a virtual care element. Nue Life’s app, for example, lets patients track their moods and prepare for their psychedelic experience. It can also integrate wearable information to track a patient’s heart rate and blood pressure.
“It’s really important for your providers to be able to see objective markers of how ketamine or any other psychedelic-assisted psychotherapy impacts their patients’ mental and physical health,” Morski said. “And that’s really going to be important, not only for improving patient care but also for getting these therapies covered by insurance in the future.”
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