WASHINGTON, D.C. — The Department of Veterans Affairs is launching a clinical trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, expanding federal research into psychedelic-based treatments as regulators continue evaluating their potential role in mental health care.
The study will enroll approximately 80 veterans and compare outcomes between participants receiving MDMA-assisted therapy and those receiving the same psychotherapy paired with an active placebo, according to the VA.
The randomized, placebo-controlled trial will be conducted at the VA Providence Healthcare System in Rhode Island, with participants recruited from facilities in Providence and from the VA Connecticut Healthcare System in West Haven, Connecticut.
The agency reported that it intends to share trial data with the Food and Drug Administration, which continues to evaluate psychedelic-assisted therapies for potential future approval.
“We need an all-of-the-above strategy when it comes to improving mental health treatments,” Veterans Affairs Secretary Doug Collins said. “This trial represents an important step in safely evaluating new approaches and innovations to treat Veterans with severe mental health conditions.”
The launch follows a recent executive order from President Donald Trump directing federal agencies to accelerate research, clinical trials and regulatory reviews involving treatments for serious mental illness, including psychedelic therapies.
MDMA, commonly known as ecstasy or molly when sold illicitly, remains an investigational treatment and has not been approved by the FDA for clinical use. However, the agency has granted breakthrough therapy designation to MDMA and several other psychedelic substances, including psilocybin and LSD, allowing for expedited review of research and development programs.
The VA noted that trial participants will receive pharmaceutical-grade MDMA in a controlled clinical setting under safety protocols developed in coordination with the FDA. The treatment will be paired with structured psychotherapy and monitored under federal research standards.
The department is currently involved in 19 active psychedelic-related clinical trials focused on mental health conditions, supported by more than $23 million in external funding.
VA officials emphasized that psychedelic therapies remain experimental and should not be used outside approved research settings.
“Clinical use of these therapies outside of research will only be considered by VA once FDA approval is granted,” the agency stated.
The study is registered on ClinicalTrials.gov under identifier NCT07118839.
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