The VA is preparing a new study that will examine whether MDMA-assisted therapy may be safe and useful for Veterans who are dealing with both post-traumatic stress disorder and alcohol use disorder.
The research will focus on MDMA, or methylenedioxymethamphetamine, when it is given in a supervised medical setting as part of psychotherapy. VA officials said about 80 Veterans are expected to take part in the study. One group will receive therapy with MDMA, while another group will receive the same type of therapy with an active placebo.
The trial will be led through the VA Providence Healthcare System in Rhode Island. Eligible Veterans may also be identified through VA Connecticut’s West Haven location, giving researchers access to participants from more than one VA site.
The study is focused on a difficult combination of conditions. PTSD can affect sleep, mood, relationships, memory, and daily functioning. According to SAMHSA, the Substance Abuse and Mental Health Services Administration, alcohol misuse can worsen symptoms and make recovery more difficult. By studying Veterans who have both conditions, researchers hope to learn whether this type of assisted therapy can help people with more complex treatment needs.
MDMA is still not approved for treating PTSD or alcohol use disorder outside authorized research. It remains a Schedule I controlled substance under federal law, which means it can only be used in approved research. VA said the study will use pharmaceutical-grade medication and will follow safety guidelines developed with the FDA.
The trial comes as interest in psychedelic-assisted therapy continues to grow in mental health research. Earlier studies have suggested that MDMA-assisted therapy may reduce PTSD symptoms for some patients when combined with structured therapy. A 2023 phase 3 study published in Nature Medicine found improvement in PTSD symptoms and daily functioning among adults with moderate to severe PTSD.
Federal approval has thus far remained elusive. In 2024, the FDA declined to approve an MDMA-based PTSD treatment from Lykos Therapeutics. Federal reviewers raised concerns about the research submitted to the agency and requested another late-stage study before the treatment could be considered again.
That decision is part of why the VA study matters. It gives researchers another opportunity to examine MDMA-assisted therapy under controlled conditions, this time with a Veteran population affected by both trauma symptoms and alcohol-related struggles.
Veterans can still access established PTSD care through the VA, including cognitive processing therapy, prolonged exposure therapy, and EMDR. The department also lists medications such as paroxetine, sertraline, and venlafaxine among the options with strong evidence for treating PTSD symptoms.
The VA has warned that Veterans should not try to use MDMA, psychedelics, or other unprescribed substances on their own. Any future use of psychedelic-assisted therapy in VA care outside of a research setting still requires FDA approval.
Author: Rikki Almanza
Rikki is a Web Content Coordinator for the American Legion, Department of California. With a deep-rooted family connection to the military, Rikki is committed to using her skills and knowledge to provide valuable assistance and resources to servicemembers and veterans.
