The U.S. Department of Veterans Affairs (VA) is set to fund its first psychedelic-assisted therapy study since the 1960s, signaling a potential shift in the approach to treating veterans with post-traumatic stress disorder (PTSD) and alcohol use disorder. The study, supported by a $1.5 million grant, will investigate the effectiveness and safety of MDMA (3,4-methylenedioxymethamphetamine) in conjunction with therapy.
Study Details and Objectives
The research, affiliated with Brown and Yale universities, is scheduled to begin in 2025 at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut. The primary goal is to evaluate how MDMA-assisted therapy can aid veterans struggling with PTSD and alcohol use disorder. Researchers aim to understand if MDMA can increase emotional openness, reduce fear, and promote introspection during therapy sessions, potentially leading to better outcomes for patients who have not responded well to traditional treatments.
Current PTSD Treatment Landscape
Currently, the first-line treatment for PTSD typically involves selective serotonin reuptake inhibitors (SSRIs) and various forms of psychotherapy. However, studies indicate that SSRIs are ineffective for an estimated 35% to 47% of individuals, and many patients engaged in trauma-focused psychotherapy continue to experience symptoms or drop out of therapy. This highlights a significant unmet need for alternative and more effective treatments.
MDMA-Assisted Therapy: A Potential Solution?
MDMA, classified by the Drug Enforcement Administration (DEA) as a Schedule I substance, has shown promise in treating PTSD when combined with therapy. In 2017, the FDA granted MDMA-assisted therapy a Breakthrough Therapy Designation, but a subsequent new drug application from Lykos Therapeutics faced rejection due to concerns about study design and potential health risks. Despite this setback, the VA's decision to fund this study indicates a growing recognition of the potential benefits of psychedelic-assisted therapies.
Expert Perspectives
Dr. Steve Sugden, president of the Utah Psychiatrist Association, noted that psychedelics might be "part of a solution" for treating PTSD, offering another tool in the therapeutic arsenal. He emphasized the critical importance of therapy in conjunction with MDMA, stating that it is "almost the most important part of it."
Broader Implications and Future Research
This study is part of a broader effort to gather scientific evidence on the efficacy and safety of psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 has also authorized the study of psychedelics within the Department of Defense, indicating a growing interest in these substances as potential treatments for mental health conditions. As research progresses, there is hope that MDMA-assisted therapy and other psychedelic treatments may offer new avenues for veterans to overcome the challenges of PTSD and improve their overall quality of life.
Virginia's Stance
Adding to the momentum, a Virginia Senate committee has advanced a bill to fund clinical trials investigating the benefits of federally recognized "breakthrough therapies" for veterans' mental health-related issues, including psychedelic substances like psilocybin and MDMA. This bill, known as the Breakthrough Therapies for Veteran Suicide Prevention Act, aims to establish a dedicated fund for clinical trials, patient access, and healthcare professional training, further supporting the exploration of innovative treatments for veterans.
