The Department of Veterans Affairs (VA) issued a request for applications (RFA) for proposals from its pool of researchers to study the vast potential of methylenedioxymethamphetamine (MDMA) and psilocybin, the active compound is magic mushrooms, in treating post traumatic stress disorder (PTSD) and depression. The organization is funding this type of research for the first time in decades.
Through this new research initiative, the VA intends to collect definitive scientific evidence on the potential efficacy of MDMA and psilocybin-assisted psychotherapy (or what they call psilocybin-augmented psychotherapy) to treat veterans living with PTSD and depression.
According to The New York Times, the last time that the VA explored psychedelics as a medical treatment was in 1963, when psychedelics were being explored for treating alcoholism and mental disorders. “This is the first time since the 1960s that VA is funding research on such compounds,” the announcement reads. Four government-funded researchers spoke with The New York Times in 2022 about their respective studies involving MDMA and psilocybin as a treatment for military veterans.
Leaders echoed the organization’s support for solid evidence that could help to understand the relationship and eventually back up medical claims related to psychedelic-assisted therapy. “Our nation’s Veterans deserve the very best care, and VA is constantly supporting innovations to deliver that,” said Secretary of Veterans Affairs Denis McDonough. “This is an important step to explore the efficacy of a potential new set of promising treatments that could improve the health and quality of life for veterans.”
PTSD represents a $230 billion estimated annual economic burden in the U.S., lending to the idea that alternative treatments are desperately needed.
“Veterans and VA researchers have told us about the potential promise of psychedelics to treat mental health conditions for some time,” VA’s Under Secretary for Health Dr. Shereef Elnahal said in a statement. “Now is our chance to study this potential method of treating Veterans with PTSD and major depression across the country.” A spokesperson said that the VA had nothing additional to share to High Times.
MDMA and psilocybin are controlled substances, but research on them can be conducted via rigorous regulatory approvals, including approvals from the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA).
The FDA granted breakthrough therapy status for MDMA for treating PTSD and psilocybin for treating depression in 2018 and 2019, respectively. The announcement notes that last September, a chorus of VA and other federal clinicians, scientists, and policymakers gathered in Denver, Colorado to assess the state of existing scientific evidence regarding psychedelic-assisted therapies. That helped to provide advice to VA leadership, recommending that their team begin funding their own studies into these compounds. This guidance was based on previously published studies that show promise, yet they did not include veterans.
Researchers at Johns Hopkins learned that psilocybin-assisted therapy, along with supportive therapy, can reduce symptoms of depression for up to 12 months. In addition, 86% of participants in a recent peer-reviewed study achieved a “clinically meaningful benefit” from using MDMA to treat PTSD.
VA organizations including the American Legion, Disabled American Veterans, and mental health provider groups called for expanding research.
The National Defense Authorization Act (NDAA) for fiscal year 2024, or H.R. 2740, authorized the study of psychedelics within military populations by the Department of Defense. With this new announcement, VA will join the National Institutes of Health in supporting research that will yield insights for treating PTSD and depression.
The new RFA will allow for the critical step of directly assessing the efficacy and safety surrounding MDMA and psilocybin-assisted psychotherapy–but this time, with Veterans.
Keeping on the safe side, the VA added the disclaimer, “VA does not recommend psychedelics for use as part of a self-treatment program.”
Steps Towards Psychedelic-Assisted Therapy in the U.S.
High Times reported recently that Lykos Therapeutics (formerly known as MAPS Public Benefit Corporation or MAPS PBC) submitted an application for FDA approval after more than three decades of clinical research into the potential use of MDMA-assisted therapy for PTSD.
MAPS PBC or Lykos Therapeutics is a subsidiary of the groundbreaking psychedelics nonprofit advocacy group the Multidisciplinary Association for Psychedelic Studies (MAPS), which has been working to develop new psychedelic-based treatments for decades. After reporting promising results from two clinical trials investigating MDMA-assisted therapy as a treatment for post-traumatic stress disorder (PTSD), MAPS PBC announced in January that the company planned to submit the new drug application (NDA) to the FDA in the third quarter of 2023.
In phase 3 trials, 71% of participants reversed their PTSD diagnosis with no serious adverse events.
Research, even on medical cannabis for PTSD, has been severely hampered by its status as a schedule I narcotic under federal law.
Read full article on High Times
