In High Demand: The Rising Popularity of Psychedelic-Assisted Therapies

By Hailey White, JHBL Staff Member

In recent years, psychedelics have proven to be a promising potential treatment option in conjunction with therapy for certain mental illnesses.[i] Two drugs especially, methylenedioxymethamphetamine (MDMA) and psilocybin, have shown particular effectiveness in treating post-traumatic stress disorder (PTSD) and severe depression, respectively—so much so that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy status to both.[ii] As both MDMA and psilocybin are classified as Schedule 1 drugs by the U.S. Drug Enforcement Administration, there have been many legal as well as social obstacles in the field of psychedelic research.[iii] However state, and even the federal governments, have slowly begun to recognize the need for and benefits of psychedelics as an alternative to traditional pharmaceuticals for the treatment of mental illness.[iv]

MDMA, commonly known as ecstasy, is a psychedelic drug that has many positive psychopharmacological effects.[v] Notable effects of the drug are decreased fear, increased sense of wellbeing and sociability, increased trust, and release of serotonin and oxytocin.[vi] MDMA has shown to be especially effective in treating severe PTSD, especially in patients for which traditional treatments (therapy and/or medication) have not been effective.[vii] MDMA-assisted therapy consists of a regimen of traditional talk therapy sessions combined with drug therapy sessions.[viii] During the drug sessions, MDMA is administered over the course of eight hours.[ix] At the forefront of MDMA-assisted therapy for PTSD research is MAPS (Multidisciplinary Association for Psychedelic Studies), a non-profit organization that is “leading the psychedelic renaissance” in the United States.[x] MAPS recently finished their second Phase 3 trial; the results were extremely promising, with 88% of participants diagnosed with severe PTSD having significant reduction in their diagnostic scores.[xi] The organization is hoping to gain FDA approval for the treatment in 2023.[xii]

Psilocybin is a hallucinogenic mushroom that has been recently discovered to have great success in treating depression.[xiii] This “magic” mushroom has potent psychological effects, particularly changes in perception and awareness and relating to thoughts and feelings.[xiv] In a recent study by Johns Hopkins University, 71% of depressed participants had a clinically significant response (lasting at least 4 weeks) to psilocybin treatment, and 54% of participants met standards for total remission; most promising, the effects of this treatment may last at least one year.[xv]

Legalizing both MDMA- and psilocybin-assisted therapies would have vast benefits for society as a whole. With 350 million people suffering with PTSD globally, and millions plagued by depression, there is obviously a need for treatment.[xvi] These two therapies address the root issues of mental health struggles, versus treating the symptoms, like traditional therapies do with medication.[xvii] Also, they would provide variety in care options for those that typical options have failed.[xviii] Not to mention, the market for psychedelics was projected to grow from $2 billion in 2020 to $10.75 billion by 2027—something that may add additional incentive.[xix] With psychedelic-assisted treatments becoming more probable in the near future, now the question becomes: how do we legally do this?

In the past five years, there have been big steps taken at both the state and federal level.[xx] In 2022, the Biden administration expressed anticipation for FDA approval of both MDMA and psilocybin treatment for PTSD and depression within 2 years.[xxi] A letter released by the Substance Abuse and Mental Health Services Administration (an agency within the U.S. Department of Health and Human Services) in 2022 details the administration’s hope to assemble a federal task force to coordinate the approval and regulation of psychedelic substances.[xxii] The task force would provide guidelines to the states “addressing the complex clinical, regulatory, and public policy issues necessary for the deployment of MDMA- and psilocybin-assisted therapies.”[xxiii] At the federal level, there is also the FDA’s Right to Try Act, which allows patients who have life-threatening conditions to access certain treatment options when they have exhausted all others.[xxiv]

States have definitely made the most progress in this area in regard to legislation. On January 1, 2023, Oregon became the first state to officially legalize psilocybin with Measure 109.[xxv] It was the first state to offer a legal therapeutic framework for psilocybin use.[xxvi] Several other states also have legislation pending—Arizona is proposing a $30 million budget for psychedelic research, Missouri is proposing psilocybin as a valid treatment option—as well cities like Oakland, Denver, Ann Arbor, and even Washington, D.C. voting to decriminalize psychedelics.[xxvii] However, these reforms only loosen penalties for possession of psychedelic drugs, not legalize them altogether.[xxviii] Depending on how they handle it, Oregon could be setting an example and pave the way for other states to legalize psilocybin as well.

There are definitely potential legal implications for legalizing psychedelic-assisted therapies. One of the main issues is deciding what type of regulatory framework can address the main concerns: how to prevent misuse and harm, what will the process for approval be, how with the U.S. grow or produce the substances, how will therapists get licensed.[xxix] Another consideration should be whether or not psilocybin and MDMA should remain classified as Schedule 1 drugs.[xxx] Due to this classification, patients would be unable to obtain insurance coverage for treatment—this may effectively prevent much of the population from accessing this type of care, as sessions could cost upwards of thousands of dollars each.[xxxi]

No two people’s mental illness is alike, and therefore their treatment options should not have to be either. Especially for those who are resistant to typical treatments, psychedelic-assisted therapies could be life-changing. Hopefully 2023 will continue to bring new legislation across the states regarding this issue, and the federal government will remain open and optimistic on FDA approval.

Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.

Hailey White is a second-year law student interested in intellectual property and life sciences. Currently, she works at a small firm focusing on civil litigation and personal injury. She graduated from Fairfield University with a Bachelor of Science in behavioral neuroscience/psychology and ethics.

[i] A Renaissance of Research on Psychedelics is on the Rise, Baylor College of Med., https://blogs.bcm.edu/2022/09/02/a-renaissance-of-research-on-psychedelics-is-on-the-rise/.

[ii] Id. See MDMA Assisted Therapy for PTSD, https://maps.org/mdma/ptsd/; Legal Use of Hallucinogenic Mushrooms Begins in Oregon, https://www.nytimes.com/2023/01/03/health/psychedelic-drugs-mushrooms-oregon.html.

[iii] https://www.dea.gov/drug-information/drug-scheduling.

[iv] Biden Administration Plans for Legal Psychedelic Therapies Within Two Years, The Intercept, https://theintercept.com/2022/07/26/mdma-psilocybin-fda-ptsd/; https://www.nytimes.com/2023/01/03/health/psychedelic-drugs-mushrooms-oregon.html; https://maps.org/mdma/ptsd/.

[v] https://maps.org/mdma/ptsd/.

[vi] Id.

[vii] Id.

[viii] Id.

[ix] https://maps.org/mdma/ptsd/.

[x] Id.

[xi] https://maps.org/2023/01/05/prior-positive-results-confirmed/.

[xii] Id.