MAY 26, 2023

The Future of Psychedelic-Assisted Therapy: Opportunities and Challenges

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After decades of regulatory hurdles and societal stigma, the future of psychedelic-assisted therapy is finally gaining traction. Following years of demonization and prohibition, psychedelic drugs are on the verge of entering mainstream psychiatry, with far-reaching ramifications for a field that has seen few pharmaceutical advances in the treatment of mental disorders and addiction in recent decades. 

Therapy and medicine are currently the most effective treatments for mental health issues such as post-traumatic stress disorder (PTSD), depression, and anxiety, among others. However, for some people, especially those who do not react to conventional treatments, researchers have found a promising new approach to transformative mental health care: psychedelic-assisted therapy. 

This blog post will delve into the opportunities and challenges surrounding the future of psychedelic-assisted therapy, highlighting its potential benefits and discussing the hurdles that need to be addressed. 


In the U.S., there are currently no forms of psychedelic-assisted therapies that the government has legally sanctioned. The Drug Enforcement Agency (DEA) continues to classify psychedelics (psilocybin, LSD, and MDMA) as Schedule 1 substances, which implies they have no established medical value and a high potential for abuse. They are thus currently illegal at the federal level. 

However, clinical trials have been disproving this categorization, and some towns and states have modified their regulations to reflect this.  

In 2020, Oregon became the first state in the U.S. to vote to legalize the personal use of psilocybin. Individuals aged 21 and up are permitted to receive psilocybin at service centers when accompanied by a licensed facilitator. The law came into force in January of this year. Legislation to legalize psilocybin has also been introduced in states including Connecticut, New Jersey, and California

MDMA and psilocybin have also received "breakthrough therapy" designation from the FDA. This classification acknowledges a drug's therapeutic potential and is intended to streamline the road from research to approval. The agency has permitted a limited number of people to use MDMA under what’s known as “expanded access,” a program intended to help seriously ill patients who have not responded to other treatments test drugs that are still being studied. 

Regulators in other countries have made similar decisions. Switzerland, Canada, and Israel allow clinicians to use certain psychedelics under specific circumstances for patients with severe conditions. Jamaica and Costa Rica, among other countries, also already operate legal psilocybin clinics. 

Australia, however, will be the first country in the world to make psychedelics available for medicinal use at a national level, starting July 1. 


Improved Treatment for Mental Health Conditions 

Psychedelic-assisted therapy has demonstrated remarkable potential in addressing treatment-resistant conditions like depression, anxiety, PTSD, and addiction. Clinical trials have shown that this takes place by encouraging the growth of new connections between neurons in the brain. Studies have also demonstrated that psychedelics can induce profound experiences, leading to increased self-awareness, introspection, and a sense of connectedness. These effects can facilitate breakthroughs in therapy and help individuals address underlying psychological issues more effectively. 

Accelerated Healing 

Unlike traditional forms of therapy, psychedelic-assisted therapy has the potential to accelerate the healing process. Research has shown that a single psychedelic session can have profound and enduring effects, with individuals reporting long-lasting improvements in mood, well-being, and overall quality of life. This suggests that a relatively short treatment duration can yield significant benefits compared to traditional therapeutic approaches. “Hallucinogenic substances have the ability to reset our default mode network (DMN) immediately and for long periods of time,” explains David J. Mokler, PhD, a neuropharmacologist and advisor at psychedelic biotechnology company Havn Life. The DMN is a network of connected parts of the brain that are active when you’re not specifically thinking about or working on anything, such as when you’re daydreaming. 

Enhanced Understanding of Consciousness and the Mind 

Psychedelics have the ability to induce altered states of consciousness, providing researchers with a unique opportunity to explore the depths of human perception and consciousness. Studying the effects of psychedelics on the brain can offer insights into the underlying neurobiology of mental health conditions, ultimately leading to more targeted and effective treatments. 

Increased Focus on Holistic Healing 

Psychedelic-assisted therapy encourages a holistic approach to healing by combining the pharmacological effects of psychedelics together with psychological support, introspection, and integration. This integrative model recognizes the importance of addressing the root causes of mental health conditions and promoting overall well-being, rather than simply treating symptoms. 

Less Adverse effects 

Classical psychedelics like psilocybin and LSD bear almost no risk of overdose, long-term health effects, or addiction. Any adverse effects are short-lived, and psychiatric symptoms related to psychedelic use are ordinarily resolved within 24 hours.


Legal and Regulatory Hurdles 

Since most drugs under the psychedelic umbrella still have Schedule I status, this imposes a ceiling on many policy recommendations, especially when it comes to federal funding. This makes it increasingly challenging for researchers and clinicians to conduct studies and offer treatments. Legalization thus remains the biggest obstacle in all psychedelic therapy research. “It won’t be until we have FDA approval and/or other legislative changes that we will be able to see advances and the destigmatization of psychedelics. It’s hard to study and get FDA approval for drugs with limited safety data, so the hurdles are high, even for psilocybin”, says Dr Davis, PhD, director of the Center for Psychedelic Drug Research and Education at Ohio State University. 

Accessibility and Equity  

Ensuring access to psychedelic-assisted therapy for a diverse range of individuals is crucial. However, accessibility and equity can be challenging due to factors such as cost, availability of trained therapists, and geographic location. Research protocols may also not translate well to community clinics, which can face particular operational challenges including inconsistent referrals, high patient throughput, limited scope for follow-up, and cost pressures. 


There is little doubt that private interests will play a major role in shaping any future roll out of psychedelic-assisted therapies. There are some who worry that the drive for profit, coupled with irresponsible marketing practices, could eclipse safety measures – with potentially disastrous consequences. Dr. Charles S. Grob, a professor of psychiatry at U.C.L.A.’s school of medicine, also points to the fact that commercialization could prompt a public backlash, especially if increased availability of the drugs leads to a wave of troubling psychotic reactions. “We have to be very attentive to safety parameters, because if conditions are not properly maintained, there is a risk for some people to go off the rails psychologically,” he said.


The future of psychedelic-assisted therapy holds immense promise for transforming mental healthcare. By embracing the opportunities presented by psychedelics, we can potentially revolutionize the treatment of mental health conditions and alleviate the suffering of millions. However, it is vital to address the challenges associated with legality, safety, and integration to ensure responsible use. Collaborations between researchers, clinicians, policymakers, and industry stakeholders are crucial to drive progress in the field and ensure the ethical use of psychedelics in therapy. Through continued research, collaboration, and public awareness, we can pave the way for a future where psychedelic-assisted therapy becomes an integral part of comprehensive mental healthcare, improving the lives of individuals worldwide.

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