For the first time since the 1960s, the Department of Veterans Affairs is studying whether a psychedelic substance is effective for treating mental health conditions -- specifically, post-traumatic stress disorder or alcoholism.
The VA announced Tuesday that it awarded a grant worth up to $1.5 million over five years to VA researchers affiliated with Brown and Yale universities to explore the effects of therapy under the influence of MDMA on PTSD symptoms and alcohol use disorder.
Previous studies funded by the nonprofit Multidisciplinary Association for Psychedelic Studies, or MAPS, showed that, following MDMA-assisted therapy for PTSD, 87% of patients had significant improvement in symptoms four months after receiving treatments and 71% no longer met the diagnostic criteria for PTSD at the end of the studies.
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Federal approval of the treatment suffered a setback earlier this year, however, when a federal advisory panel considering its drug application raised concerns about the way the MAPS clinical trials were conducted and assessed, saying they may have elevated the results.
The panel recommended against approval by the Food and Drug Administration and the FDA agreed, asking for additional clinical trials before it would reconsider the application.
The VA announced in January that it planned to fund research on MDMA-assisted therapy as well as psilocybin -- the psychoactive ingredient in "magic mushrooms" -- and other psychedelic compounds for PTSD, depression and other mental health conditions.
Tuesday's announcement marks the first time in more than 50 years that psychedelic research will be conducted at VA facilities. The study, which is already underway to some extent, will take place at the VA medical center in Providence, Rhode Island, and West Haven VA Medical Center, Connecticut.
"VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health," Under Secretary for Health Dr. Shereef Elnahal said in a news release. "This study will give us better insight into the potential of MDMA-assisted therapy as a treatment for veterans."
At VA Medical Center Providence, three researchers from Brown University's Center for Alcohol and Addiction Studies already have enrolled 12 participants, according to the school.
Erica Eaton, assistant professor of psychiatry and human behavior and of behavioral and social sciences, and Christy Capone, assistant professor of behavioral and social sciences and of psychiatry and human behavior, treat patients at Providence and said in a September news release that the situation for veterans is "dire," requiring new therapies and treatment options.
"People are dying," Capone said. "There's a pretty high suicide rate among veterans. Some of the risk factors for suicide are PTSD and substance use. Veterans that have sought treatment and have not benefited are pretty demoralized."
The treatment in the study consists of sessions during which the patient takes MDMA and undergoes therapy while under the medication's influence. According to Capone, MDMA is less of a hallucinogen than other psychedelic drugs and instead promotes feelings like empathy, sociability and introspection.
It's "more about breaking down barriers and processing what's there," she said in the release.
MDMA research also is already underway at Yale University, where the Defense Department awarded a three-year, $1 million grant in 2023 to study the effects of MDMA and a synthetic form of the drug known as methylone on veterans with PTSD.
During the MAPS clinical trials, patients reported side effects such as blurred vision, muscle tightness, decreased appetite and dilated pupils. But three participants also reported suicidal thoughts, and seven participants experienced cardiovascular issues.
VA officials said the research at its facilities will follow strict safety protocols and entail "pharmaceutical-grade MDMA" and that participants will be closely monitored throughout the study.
They also urged veterans not to try to treat themselves with MDMA or any other unprescribed substances.
"Psychedelic drugs are a class of substances that alter consciousness or awareness and can be organically or synthetically produced. To prevent serious self-injury or harm, VA strongly discourages self-medicating," officials said in the release.
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