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The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.
The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy.
The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations.
In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.
The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.
However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed.
The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.
The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.
In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.”
Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”
The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.
The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy.
The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations.
In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.
The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.
However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed.
The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.
The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.
In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.”
Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”
The first study funded by the US Department of Veterans Affairs (VA) for psychedelic-assisted therapy since the 1960s is currently enrolling veterans. Researchers are set to evaluate the potential of methylenedioxymethamphetamine (MDMA) for veterans with posttraumatic stress disorder (PTSD) and alcohol use disorder.
The grant—about $1.5 million over 5 years—will fund a randomized, placebo-controlled trial at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut by VA researchers affiliated with Brown University and Yale University. Pharmaceutical-grade MDMA will be used, and some participants will be randomly selected to receive an active placebo (lower dose of MDMA). MDMA is a psychedelic compound believed to increase emotional openness, reduce fear, and promote introspection during therapy.
The study is part of the VA’s broader effort to gather definitive scientific evidence on the potential efficacy and safety of psychedelic compounds used in conjunction with psychotherapy to treat PTSD, depression, and related mental health conditions. Veterans service organizations like the American Legion and Disabled American Veterans in addition to mental health clinician groups have also called for expanded research into psychedelic compounds. The National Defense Authorization Act for fiscal year 2024 also authorized the US Department of Defense to perform research on psychedelics within military populations.
In September 2023, VA and other federal clinicians, scientists, and policy makers assessed the state of scientific evidence regarding psychedelic-assisted therapies. The working groups provided advice to VA leadership, including the recommendation for the VA to begin funding its own research into these areas of care.
The guidance was based on previously published studies that have found encouraging results but included few or no veteran participants. For example, a confirmatory phase 3 study by the MAPP2 Study Collaborator Group involved 104 patients, of whom only 16 were veterans.
However, the findings of that study underscored the potential of the treatment: MDMA significantly improved PTSD symptoms and functional impairment, compared with placebo with therapy over 18 weeks. Notably, 45 of 52 (86%) participants treated with MDMA achieved a clinically meaningful benefit, and 37 of 52 (71%) participants no longer met criteria for PTSD by the end of the study. Consistent with an earlier study, no new major safety issues were reported. Common treatment-emergent adverse effects were like those of previous research and consistent with expected effects of MDMA. MDMA did not appear to increase the risk of suicidal ideation, and no suicidal behavior was observed.
The VA researchers has conducted a limited number of small studies on psychedelics in VA facilities using non-VA funding. “VA is on the cutting edge of clinical research for veteran health, including in the investigation of psychedelics for mental health,” said Under Secretary for Health Shereef Elnahal, MD.
The FDA granted breakthrough therapy status for MDMA in the treatment of PTSD and psilocybin for the treatment of depression in 2017 and 2018, respectively, based on promising preliminary research evidence. However, in June 2024 an FDA panel voted against approving a MDMA therapy for PTSD, citing concerns about research practices, a lack of diversity in the trials, and a failure to provide data on adverse effects such as potential for abuse.
In August, the FDA formally rejected the treatment and called for another phase 3 study. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. “This is the epitome of bureaucratic red tape—and the result is people will keep dying.”
Meanwhile, VA Press Secretary Terrence Hayes said in a statement: “VA is committed to high-quality research that safely promotes the health of our nation’s Veterans … VA anticipates that additional insights on the efficacy and safety of these therapies will add to the broader body of knowledge on MDMA-assisted psychotherapy.”