VA launches MDMA trial for veterans with severe mental illness

The Department of Veterans Affairs on Tuesday announced a new clinical trial that will test whether MDMA-assisted therapy can safely and effectively treat severe mental health conditions in veterans, including post-traumatic stress disorder and alcohol use disorder, as the agency expands its research into psychedelic-based treatments under a recent White House directive.

The study, which VA said will enroll about 80 veterans, will compare outcomes for participants receiving MDMA-assisted therapy with those receiving the same psychotherapy paired with an active placebo. The trial is scheduled to take place at the VA Providence Healthcare System, with recruitment from the Providence campus and the VA Connecticut Healthcare System in West Haven, Conn.

VA said it is coordinating with the Food and Drug Administration and plans to share the trial data with the agency. The department said the research is being conducted in a controlled clinical setting with pharmaceutical-grade drugs, strict safety protocols developed with the F.D.A. and structured psychotherapy.

The announcement follows President Trump’s executive order titled “Accelerating Medical Treatments for Serious Mental Illness,” which calls for more clinical trial participation and faster development and approval pathways for psychedelic drugs. VA Secretary Doug Collins said in a statement that the department needs “an all-of-the-above strategy” to improve mental health treatment for veterans.

The agency said the trial is part of a broader research effort already underway across the VA system. It said it is involved in 19 active clinical trials focused on psychedelic therapies for mental health conditions, supported by more than $23 million in external funding.

MDMA, short for methylenedioxymethamphetamine, is a synthetic drug that alters perception and awareness. The F.D.A. has granted breakthrough therapy designation to several psychedelic substances, including MDMA, psilocybin and LSD, a status intended to speed review of drugs that may offer substantial improvement over existing treatments.

VA said it will consider clinical use of psychedelic therapies outside research only after F.D.A. approval. The department also warned veterans not to try to self-medicate or replace established mental health care with psychedelics or other unprescribed substances, saying evidence-based treatments are already available through VA facilities.

The trial is registered on ClinicalTrials.gov under NCT07118839.