A top U.S. Department of Veterans Affairs (VA) official is touting the first agency-funded psychedelics study since the 1960s, exploring the efficacy of MDMA-assisted...

A top U.S. Department of Veterans Affairs (VA) official is touting the first agency-funded psychedelics study since the 1960s, exploring the efficacy of MDMA-assisted therapy for veterans with post-traumatic stress disorder (PTSD) and alcohol use disorder.

VA Under Secretary for Health Shereef Elnahal discussed the research initiative during a panel that also featured Sen. Kyrsten Sinema (I-AZ) and Rep. Morgan Luttrell (R-TX), who have separately advocated for psychedelics reform.

In a LinkedIn post last week, Elnahal promoted the panel hosted by a Politico reporter at the HLTH conference where VA announced “our first study that will be funded out of VA’s own research dollars, which will investigate the effectiveness of MDMA-assisted psychotherapy for Veterans with PTSD and alcohol-use disorder.”

“Specifically, that study will use low-dose MDMA in the placebo arm in an attempt to address FDA’s concerns about patients knowing what study arm they’re part of—addressing ‘functional unblinding’ will get the scientific community one step closer in better assessing the efficacy and safety of this novel therapy,” he said of the project, which will be led by the Providence VA Medical Center in Rhode Island. “This is the first study that VA is funding investigating psychedelics since the 1960s.”

The VA official also noted that he recently spoke about the issue with Rep. Jack Bergman (R-MI)—co-founder of the Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus—as well as former Rep. Tim Ryan (D-OH) at a separate psychedelics conference. That conversation centered around “what the future holds for getting more access to this potentially game-changing therapy,” Elnahal said.

VA “must lead on this encouraging area of investigation so that we can continue to build trust with Veterans contending with these severe health conditions. And we will,” he said.

Elnahal and Sinema also recently attended an event where VA officials were able to share findings from their study on MDMA-assisted psychotherapy.

Rachel Yehuda, director of mental health at VA’s James J. Peters Veterans Affairs Medical Center, said following the event that the agency has produced “stunning and robust results” from its first-ever clinical trial into MDMA therapy.

“The VA continues to take leadership in the psychedelic arena, and it is coming from the top! The VA will fund psychedelic research, and when the time is right, move to ensure safe clinical implementation,” Yehuda, who also serves as director of the Center for Psychedelic Psychotherapy and Trauma Research at Mount Sinai, said at the time.

This comes as FDA faces criticism from advocates and researchers after denying an application to approve the novel therapy based on separate research.

Just one day before FDA declined to approve a new drug application for MDMA-assisted therapy, Yehuda said she’s been asked how that decision might affect the department’s own work. She said the answer is: “Double down on the research. Keep generating the data and the cases. The nature of challenge is, well, that it is challenging. But I am optimistic.”

Bipartisan lawmakers separately staged an event at the U.S. Capitol calling for the MDMA approval by FDA and also launched an art installation memorializing military veterans who died by suicide.

Meanwhile, the U.S. House of Representatives recently approved amendments to a large-scale spending bill that would authorize VA doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.

In August, the Senate Appropriations Committee also passed report language for appropriations legislation conveying concerns about restrictions on marijuana and psychedelics research imposed by current prohibition.

Meanwhile, a Drug Enforcement Administration (DEA) administrative judge has denied the federal agency’s request to block a series of witnesses and evidentiary exhibits in a forthcoming hearing on its plans to ban a pair of psychedelic compounds used for research purposes.

Last month, advocates in support of expanding access to psychedelic-assisted therapy for America’s military veterans released an informational guidebook that backers say “responds to the demand for alternative treatment solutions and equips veterans with practical, clinically-backed strategies to safely explore these therapies.”

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Photo courtesy of Pretty Drugthings on Unsplash.

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