(The Center Square) – The U.S. Department of Veterans Affairs on Tuesday launched a clinical trial testing MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, one of 19 psychedelic studies the agency is funding through $23 million in external grants.
The study, which received federal funding in December 2024, began enrolling participants on May 18 and will include about 80 veterans at VA facilities in Providence, Rhode Island and West Haven, Connecticut.
Participants will be randomly assigned to receive MDMA-assisted psychotherapy or the same therapy with an active placebo. Results are expected in May 2030.
The launch follows President Donald Trump's April 18 executive order directing federal agencies to expand research into psychedelic treatments for serious mental health conditions.
The order also allocates $50 million through the Advanced Research Projects Agency for Health, ARPA-H, for state psychedelic programs, funding distinct from the VA trial.
The order cites more than 6,000 veteran suicides annually, more than twice the rate of non-veterans.
"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," VA Secretary Doug Collins said.
MDMA, also known as ecstasy, is a Schedule I controlled substance researchers say may increase emotional processing and reduce fear during psychotherapy.
Dr. Lynnette Averill, chief science officer of Reason for Hope and the Veterans Mental Health Leadership Coalition, said the launch reflects delayed progress.
"The VA initially announced this study had received funding in December 2024, which shows how long and slow the process can be to initiate these psychedelic-assisted therapy trials," she told The Center Square.
The Food and Drug Administration declined to approve MDMA-assisted therapy for PTSD in August 2024, citing concerns about safety data, durability of benefit and trial design. It recommended additional randomized studies, the structure the VA trial is designed to follow.
VA said it is coordinating with the FDA and will share data from the trial. Treatments will be delivered under controlled conditions using pharmaceutical-grade MDMA. The principal investigator is Erica M. Eaton of the Providence VA Medical Center.
In May, 31 House members urged then-FDA Commissioner Martin Makary to expedite review of MDMA-assisted therapy and coordinate with VA research efforts. The bipartisan letter included U.S. Reps. Dan Crenshaw, R-Texas, and Alexandria Ocasio-Cortez, D-N.Y. Makary departed the agency two weeks after the letter. Kyle Diamantas is now serving as acting commissioner, with the principal deputy position vacant.
The Multidisciplinary Association for Psychedelic Studies, which has conducted MDMA research, welcomed the executive order but said progress should remain "grounded in rigorous science, careful evaluation, and a commitment to patient safety."
Not all advocacy groups are supportive. Kevin A. Sabet, president and CEO of Smart Approaches to Marijuana and its affiliated Foundation for Drug Policy Solutions, said the FDA's 2024 rejection raised unresolved concerns.
"There would need to be substantial evidence that the egregious issues in those clinical trials have been resolved," he said.
Averill, who is also leading a psilocybin trial for veterans in Texas, raised questions about how broadly results will apply.
"Many of the Veterans with the most severe or complex presentations may not qualify," she said, citing medication requirements and other eligibility restrictions. "It also means we need to carefully consider how applicable the eventual findings will be to the broader real-world Veteran population most in need."
The study was funded through a $1.5 million, five-year federal grant announced in December 2024, according to a VA news release at the time. VA did not respond to questions about whether additional funding has been attached to the trial or what has changed.
VA discourages veterans from self-medicating with psychedelics outside clinical trials and says approved treatments are available through VA health care.
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