The U.S. Department of Veterans Affairs today announced a new clinical trial to evaluate the safety and efficacy of methylenedioxymethamphetamine-assisted therapy, or MDMA-assisted therapy, for the treatment of severe mental health disorders, including posttraumatic stress disorder and alcohol use disorder.
The new trial comes after President Trump’s recent executive order on “Accelerating Medical Treatments for Serious Mental Illness.” The order aims to increase clinical trial participation and accelerate innovative research models and drug approvals for psychedelic drugs.
VA’s trial, titled “A Randomized Controlled Trial of MDMA-Assisted Therapy for PTSD and Alcohol Use Disorder in U.S. Veterans,” will enroll approximately 80 Veterans and compare outcomes between those receiving MDMA-assisted therapy and those receiving identical psychotherapy with an active placebo. VA is coordinating with the U.S. Food and Drug Administration (FDA) and intends to share data from the trial with FDA.
“We need an all-of-the-above strategy when it comes to improving mental health treatments, and under President Trump, that’s exactly what VA is working to deliver,” said VA Secretary Doug Collins. “This trial represents an important step in safely evaluating new approaches and innovations to treat Veterans with severe mental health conditions.”
The randomized, placebo-controlled trial of MDMA-assisted therapy will take place at VA Providence Healthcare System, and Veterans will be recruited for the trial from the Providence, Rhode Island, campus and VA Connecticut Healthcare System in West Haven, Connecticut.
The health and safety of Veterans who choose to participate in this trial is VA’s top priority. Investigational treatments will be delivered in a safe, controlled, clinical setting using pharmaceutical grade drugs under careful quality controls, stringent safety protocols that were developed with FDA, and in a setting that includes structured psychotherapy.
Currently, VA is involved in 19 active clinical trials focused on psychedelic therapies for mental health conditions that are supported by more than $23 million in external funding. All VA research, including research into psychedelics, is conducted under strict safety protocols and in full compliance with federal guidelines.
Psychedelic drugs are a class of substances that alter consciousness or awareness and can be organically or synthetically produced. The FDA has granted breakthrough therapy designation to several psychedelic substances, including MDMA, psilocybin and LSD, allowing for expedited review of these drugs. Clinical use of these therapies outside of research will only be considered by VA once FDA approval is granted.
VA strongly discourages self-medicating or attempting to replace other mental health treatment options with psychedelics or any other unprescribed substances. Proven, evidence-based treatments, are currently available at VA facilities to treat Veterans with mental health conditions. Veterans should always consult their health care providers before making any treatment decisions.
The trial is registered with ClinicalTrials.gov (NCT07118839).