The federal authorization that directed the Department of Veterans Affairs to fund and conduct MDMA-assisted therapy studies for veterans with PTSD — parallel to, but separate from, the NDAA provision.
Congress approved the first federal budget language directing VA funding toward psychedelic research when it passed the FY2024 Consolidated Appropriations Act in March 2024.
The law encouraged the VA to use up to $20 million to conduct nationwide trials of breakthrough psychedelic therapies, specifically naming MDMA-assisted therapy and psilocybin. The language was "encourage" rather than "mandate," giving VA leadership discretion over how to spend the money.
The VA acted quickly. In December 2024, the agency announced a five-year grant of up to $1.5 million — the first VA-funded psychedelic research in more than 50 years.
The VA had not funded psychedelic research since the 1960s. Decades of federal scheduling made internal VA funding impossible, even as private sponsors like MAPS ran veteran-specific MDMA studies outside the VA system. Congressional appropriations language changed that legal and political calculus overnight.
The VA trial targets a specific, underserved patient group: veterans who have both PTSD and alcohol use disorder at the same time — a co-occurring condition most MDMA studies have excluded.
Most prior MDMA-assisted therapy trials, including the MAPS Phase 3 studies that Lykos submitted to the FDA, excluded participants with active alcohol use disorder. The VA study fills that gap. Veterans with co-occurring PTSD and AUD are common, but the research field has largely left them out. That omission is what makes this trial scientifically distinct from the commercial development path.
The full study title is "A Randomized Controlled Trial of MDMA-Assisted Therapy for PTSD and Alcohol Use Disorder in U.S. Veterans." It is registered on ClinicalTrials.gov under NCT05943665.
About 80 veterans will take part. Half will receive MDMA-assisted psychotherapy. The other half will receive the same psychotherapy sessions with a low, active placebo dose of MDMA. This design allows researchers to control for the non-drug effects of therapy.
Participants receive two monthly MDMA doses paired with psychotherapy sessions before and after each dose. Results are expected by May 2030.
The VA MDMA trial runs at two VA medical centers: the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut.
Brown University researchers lead the Providence site. Yale University researchers lead the West Haven site. Enrollment opened in May 2026. The study will enroll approximately 80 veterans across both sites.
To qualify, veterans must have a diagnosis of both PTSD and alcohol use disorder. Veterans outside Rhode Island and Connecticut are not eligible for this specific trial. Other VA psychedelic research initiatives may open additional sites in future funding cycles.
Before this trial, MDMA studies involving veterans were funded by private sponsors — primarily MAPS PBC — and conducted at non-VA sites. Some VA clinicians participated as co-investigators, and VA Loma Linda Healthcare ran a separately funded pilot. This December 2024 grant is the first time the VA's own research budget supported an MDMA study, a distinction that matters for how results will be used in VA clinical practice decisions.
The VA MDMA study and the DoD NDAA psychedelic provision are two separate federal programs with different populations, oversight structures, and funding amounts.
The DoD NDAA provision — enacted in December 2023 — covers active-duty service members still in uniform. It sits under Department of Defense oversight and received $10 million. The VA program covers veterans who have left active service. It sits under VA oversight and drew from the $20 million the FY2024 appropriations bill directed toward VA research.
| Feature | VA MDMA Study (FY2024 Appropriations) | DoD NDAA Provision (FY2024 NDAA) |
|---|---|---|
| Who it covers | Veterans (post-service) | Active-duty service members |
| Overseeing agency | Department of Veterans Affairs | Department of Defense |
| Legislative vehicle | FY2024 Consolidated Appropriations Act | FY2024 National Defense Authorization Act |
| Funding amount | Up to $20 million encouraged; $1.5M awarded | $10 million |
| Substances in scope | MDMA and psilocybin | MDMA, psilocybin, ibogaine, 5-MeO-DMT |
| Reporting requirement | None specified | Defense Secretary reports to Congress annually for 3 years |
| Trial sites | Providence RI; West Haven CT | DoD-designated military medical sites |
When the VA program matters more: for policy affecting veterans after discharge, VA clinical practice guidelines, and VA formulary decisions. When the DoD program matters more: for service members still on active duty, DoD mental health policy, and military readiness research. Both programs can influence each other's findings over time. See our NDAA psychedelics provision guide for the DoD side.
The FDA's August 2024 rejection of Lykos Therapeutics' MDMA application did not stop the VA study — and understanding why requires knowing how research authorization differs from commercial approval.
Lykos (the spinout from MAPS PBC) sought FDA approval to market MDMA as a commercial prescription drug. The FDA issued a Complete Response Letter in August 2024 asking for a new Phase 3 trial and flagging concerns about study design and data integrity. Lykos laid off about 75% of its staff within days.
The VA study operates under a separate legal mechanism — an Investigational New Drug (IND) authorization from the FDA, which allows controlled research with Schedule I substances without commercial approval. These are different tracks. The rejection of one company's marketing application does not close the IND track for government-funded research.
The rejection delayed the commercial path to MDMA prescription therapy for the general public by several years. For veterans, this means VA-funded research remains the primary route to potential access. If the VA trial succeeds, it could support a future NDA from Lykos or another sponsor — or provide the basis for expanded VA access under a compassionate-use or expanded-access framework before commercial approval arrives.
For more on how MDMA therapy works and the current regulatory landscape, see our substance guide.
President Trump signed an executive order in April 2026 directing federal agencies to accelerate psychedelic research for veterans with mental illness.
The order, titled "Accelerating Medical Treatment for Serious Mental Illness," cited the veteran suicide rate as a key reason for action. It directed the Secretary of Health and Human Services to allocate $50 million through the Advanced Research Projects for Health (ARPA-H) program to match state investments in psychedelic research. The FDA was directed to fast-track Commissioner's National Priority Vouchers for psychedelic drugs with Breakthrough Therapy Designation.
For the VA MDMA trial specifically, the executive order did not change the study design or funding already in place. But it created political and bureaucratic momentum for the VA to expand sites, increase enrollment, and expedite data review. The VA trial went from announcement to first enrolled veterans in roughly 18 months — faster than most multi-site government trials reach that milestone.
Track the full federal and state policy landscape at our psychedelic legalization tracker.
Yes. The FY2024 Consolidated Appropriations Act encouraged the VA to spend up to $20 million on psychedelic research, including MDMA-assisted therapy. The VA responded by funding a five-year, $1.5 million study at VA medical centers in Providence, Rhode Island, and West Haven, Connecticut. Enrollment began in May 2026.
The study tests MDMA-assisted therapy for veterans who have both PTSD and alcohol use disorder at the same time. About 80 veterans will receive either MDMA-assisted psychotherapy or an active placebo (a low dose of MDMA) plus the same psychotherapy. Results are expected in May 2030.
The DoD NDAA provision targets active-duty service members and is overseen by the Department of Defense. The VA program targets veterans who have already left service and is funded and overseen by the Department of Veterans Affairs. The DoD received $10 million for its program; the VA was encouraged to use up to $20 million.
No. The VA study continued after the FDA rejected Lykos Therapeutics' application for commercial MDMA therapy in August 2024. VA-funded research operates under an Investigational New Drug authorization, not commercial approval. The FDA rejection delayed a path to clinical prescription use but did not stop VA research.
The VA MDMA trial runs at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut. Researchers from Brown University and Yale University are leading the study.
Enrollment opened in May 2026 at two VA sites: Providence, Rhode Island, and West Haven, Connecticut. The study targets veterans with both PTSD and alcohol use disorder. Veterans outside those areas are not currently eligible for this specific trial, though other VA psychedelic studies may open additional sites.
Federal law on psychedelics changes fast. Our tracker follows VA and DoD programs, executive orders, congressional bills, and FDA decisions in one place.
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