In January, the VA made a public commitment to fund psychedelic clinical trials for the first time since the ‘60s. Now, the agency has revealed the first of those studies that it will fund from its own coffers: a trial of MDMA-assisted psychotherapy for veterans with PTSD and alcohol use disorder (AUD).

According to VA Under Secretary for Health Shereef Elnahal, the study will “use low-dose MDMA in the placebo arm in an attempt to address FDA’s concerns about knowing what study arm they’re part of”. “[A]ddressing ‘functional unblinding’”, Elnahal continued, “will get the scientific community one step closer in better assessing the efficacy and safety of this novel therapy.”

The study will be led by researchers at Providence VA Medical Center in Rhode Island.

Elnahal is certainly an advocate for advancing the investigation of psychedelics within the VA and ensuring the agency puts its money where its mouth is. He told the audience at HLTH conference in Las Vegas recently that he “did not feel awesome” when he heard that Lykos Therapeutics’ NDA had been rejected by the agency, and just last week we reported that the prospect of the agency taking a more direct role in funding a portion of the company’s fresh Phase 3 was ‘definitely a possibility’, according to the Under Secretary (see VA Funding of Lykos Phase 3 ‘Definitely a Possibility’).

For now, it looks like VA researchers will try to address key concerns that the FDA had with Lykos’ submission, starting with functional unblinding. It will be interesting to see how it gets on with low-dose MDMA, however, as Lykos had steered clear of that strategy after observing in a few small studies that lower doses of the drug could be anxiogenic (see our earlier reporting for more). But, when we spoke with Lykos’ newly-appointed Chief Medical Officer, David Hough, back in September, he left the strategy on the table…