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The Breakthrough Therapies Act: Paving a Bright Future for Mental Health

By Ashley Barnes, M.S.


Reviewed by: Mark Hrymoc, MD


The Breakthrough Act


On November 17, 2022, Senator Cory Booker (D-N.J.) and U.S. Senator Rand Paul (R-KY) introduced the Breakthrough Therapies Act, “legislation that would enable the Drug Enforcement Agency (DEA) to make the findings necessary to transfer breakthrough therapies involving Schedule I substances such as MDMA and psilocybin from Schedule I to Schedule II, which could help facilitate a phased roll-out of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs” (Booker, 2022).


The bill would also remove impeding federal regulations that obstruct research on potential “breakthrough therapies,” or treatment options that show profound improvement over any currently available treatments.


“We urge Congress to swiftly pass the Breakthrough Therapies Act, which responsibly reduces the barriers to research and limited access of potentially life-saving treatments like MDMA- and psilocybin-assisted therapy,” said Martin R. Steele, a retired Lieutenant General in the United States Marine Corps., Chief Executive Officer of Reason for Hope, and head of the recently formed Veteran Mental Health Leadership Coalition. “Veterans should not be forced (nor should anyone else) to leave the country - at great expense - to access breakthrough therapies that can be safely provided and further studied in real-world settings here at home."


Current Research


The research that has been conducted on psilocybin and methylenedioxymethamphetamine (MDMA) is promising in terms of impact on mental health symptoms and outcomes.


Psilocybin mushrooms, commonly known as “magic mushrooms,” are naturally occurring polyphyletic fungi that have hallucinogenic effects when ingested. Studies on psilocybin show “potentially positive benefits with minimal safety concerns for…use in suicidality, anxiety disorders, OCD, alcohol use disorder, and tobacco use disorder with improvement in target symptoms”(Daniel & Haberman, 2018). A recent Johns Hopkins study found that psilocybin treatment led to a substantial decrease in depression symptoms, and the severity of the mental illness stayed low one, three, six and 12 months after treatment was completed (Gukasyan et al., 2022).


MDMA, commonly known as “ecstasy” or “molly” is a synthetic drug that acts as a stimulant and hallucinogen. Research points to MDMA as having an efficacious impact on post-traumatic stress disorder (PTSD) symptoms, with one study illustrating the potential benefit of MDMA-assisted therapy for PTSD over the FDA-approved first-line pharmacotherapies sertraline and paroxetine, which have both exhibited smaller effect sizes in pivotal studies than the effect size in the present study - in other words, participants’ PTSD symptoms decreased significantly after having received MDMA-assisted therapy (Mitchell et al., 2021).


With the help of the Breakthrough Therapies Act, research can continue safely without the burdensome restrictions that were present before.


Ketamine Therapy Center


Ketamine Therapy Center is a treatment branch from the Mental Health Center that specializes in ketamine infusion therapy. We plan to offer even more types of psychedelic treatments and assisted therapies when it is permissible to do so, as we believe in evidence-based treatment approaches that have the power to transform one’s life.


Our doctors offer Ketamine Therapy Evaluations to thoroughly assess patients for ketamine therapy candidacy; from here, they collaborate with patients to develop treatment plans. Our office in the Cedars- Sinai Medical Office towers houses rooms specially designed for patient comfort. Our highly experienced and talented nurses are well-versed in ketamine infusion therapy and help patients feel comfortable as they move through the treatment process. Our therapists are trained in Ketamine Assisted Psychotherapy and offer therapeutic guidance to enhance the psychological benefit of the treatment while simultaneously creating a grounded and safe space.


For more information, please do not hesitate to explore our website or contact our office!



References

Booker, Cory (2022). Booker, paul introduce bipartisan legislation to promote research and access to potential life saving drugs: U.S. senator Cory Booker of New Jersey.Retrieved February 17, 2023, from https://www.booker.senate.gov/news/press/booker-paul-introduce-bipartisan-legislation-to-promote-research-and-access-to-potential-life-saving-drugs

Daniel, J., & Haberman, M. (2018). Clinical potential of psilocybin as a treatment for mental health conditions. Ment Health Clin. 2018 Mar 23;7(1):24-28. doi: 10.9740/mhc.2017.01.024. PMID: 29955494; PMCID: PMC6007659.

Gukasyan, N., Davis, A.K., Barrett, F.S., et al. (2022). Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Journal of Psychopharmacology. 2022;36(2):151-158. doi:10.1177/02698811211073759

Mitchell, J.M., Bogenschutz, M., Lilienstein, A. et al. (2021). MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 27, 1025–1033 (2021). https://doi.org/10.1038/s41591-021-01336-3


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