After decades of regulatory hurdles, societal stigma, and scientific skepticism, psychedelic-assisted therapy is finally stepping into the spotlight as a promising option for behavioral health care. Interest in psychedelics is surging, fueled by clinical research, evolving state regulations, and the potential for FDA approval. Experts suggest that 2023 could be a landmark year for the field, with legalization efforts gaining traction, the first FDA approvals on the horizon, and innovative providers expanding access to patients across the country.
“We see [acceptance] happening both on the political and regulatory levels, as well as on a grassroots level,” said Ronan Levy, co-founder and CEO of Field Trip Health & Wellness, a leading provider of psychedelic-assisted therapy in North America. Field Trip operates in major U.S. cities, including New York City, Chicago, Atlanta, Seattle, Washington, D.C., Los Angeles, San Diego, and Houston. The organization combines ketamine, therapy, and wellness support to deliver psychedelic-assisted therapy both in-office and in-home, making treatment accessible to a wide range of patients.
The Expanding Role of Psychedelics in Behavioral Health
Historically, psychedelics were stigmatized and classified as Schedule 1 drugs. However, research shows that substances such as ketamine, LSD, MDMA, and psilocybin may provide significant benefits when paired with therapy. Psychedelic-assisted therapy is increasingly being used to address conditions such as post-traumatic stress disorder (PTSD), alcohol use disorder (AUD), depression, anxiety, and other mental health challenges.
Ketamine, a Schedule 3 drug, has been approved for clinical use, including the FDA-approved nasal spray Spravato for adults with treatment-resistant depression. During the COVID-19 public health emergency, remote prescribing regulations allowed for the expansion of virtual and in-home psychedelic-assisted therapy, helping more patients access care safely.
State-Level Legalization Moves the Dial
State legislation is accelerating access to psychedelic-assisted therapy. Oregon became the first state to legalize psilocybin for personal use in 2020, allowing adults 21 and older to access it under the supervision of a licensed facilitator. Oregon’s law does not require a mental health diagnosis, reflecting a broader approach to safety and access.
“Instead of working on inclusion criteria, they work on exclusion criteria,” said Levy. “Everyone of a certain age can participate unless you have severe bipolar disorder or schizophrenia. It’s a very smart approach because you limit the downside while increasing access to psychedelic-assisted therapy.”
Colorado voters passed similar legislation in 2022, legalizing supervised psychedelic use for adults 18 and older and creating a Natural Medicine Advisory Board to guide regulation. New Hampshire and California are exploring comparable measures.
Clinical Evidence and Emerging Research
Recent studies are validating the efficacy of psychedelic-assisted therapy. A JAMA study found that psilocybin-assisted treatment significantly reduced heavy drinking days in patients with AUD. MAPS’ Phase 3 trials of MDMA-assisted therapy for PTSD showed that 88% of participants experienced significant symptom reduction, compared to 60% of those in the placebo group. FDA breakthrough designation for MDMA therapy is expected to result in evaluation later in 2023.
Greg Mayes, CEO of Reunion Neuroscience, noted, “All expectations are that the product could be on the market in late 2023 or early 2024. This will be an important first mover in psychedelic-assisted therapy becoming mainstream.”
Expanding Treatment Applications
Providers are exploring new areas for psychedelic-assisted therapy, including eating disorders, anorexia, end-of-life distress, and palliative care. Field Trip Health plans to partner with MAPS to research MDMA-assisted therapy for eating disorders. Reunion Neuroscience focuses on postpartum depression and other niche indications, enabling smaller, faster trials and faster access to data.
Digital tools are also being integrated into care. Nue Life’s app tracks mood, heart rate, and blood pressure, helping clinicians measure objective outcomes and improve insurance coverage for psychedelic therapy.
Dr. Morski explained, “It’s really important for providers to see objective markers of how ketamine or any other psychedelic-assisted therapy impacts patients’ mental and physical health. This is key for improving care and achieving broader adoption.”
Looking Ahead
With regulatory changes, emerging research, and growing provider networks, psychedelic-assisted therapy is poised to become a mainstream behavioral health option. As more states consider legalization and FDA approvals advance, patients may soon access a wider range of treatments safely, effectively, and virtually. The next few years will be critical in shaping regulations, determining patient eligibility, and expanding the scope of psychedelic therapy to new behavioral health conditions.
