VA-sponsored psychedelics studies get green light in FY24 budget

by Tommy Grant

The Department of Veterans Affairs can now begin trials of certain psychedelic therapies, after Congress passed the fiscal 2024 budget for the VA that included an amendment on psychedelic research.

The bill, which passed on March 8, encourages the VA to use $20 million to conduct nationwide trials of certain breakthrough psychedelic therapies, which include the use of MDMA-AT, also known as ecstasy or molly, and psilocybin, also known as magic mushrooms. A “breakthrough therapy” is a designation the U.S. Food and Drug Administration gives to drugs used to treat serious conditions, with initial studies showing “substantial improvement” over available medicines.

“We are truly grateful to our congressional champions, who’ve worked hand-in-hand with us to get federal skin in the game for MDMA-AT research,” Juliana Mercer, a Marine Corps veteran and veteran advocacy director for the group Healing Breakthrough, said in a statement. “We’re witnessing the federal government take unprecedented action to bring healing to our hurting veterans.”

Politico first reported on the psychedelic therapy provision, which was introduced by Psychedelic Advancing Therapies Caucus co-chairs Reps. Jack Bergman (R-Mich.) and Lou Correa (D-Calif.).

There are currently eight psychedelic therapy trials taking place across the country through the VA, Mercer said, but all of those studies are philanthropically funded. Mercer previously told Military Times that a lack of federal funds hinders efforts to get such therapies in the hands of veterans who need them.

The passage of the amendment comes at a time when various agencies within the federal government are expanding research into the medicinal properties of psychedelics. Lawmakers in December passed the first-ever provision allowing the Defense Department to fund federal or state studies of the effects of psychedelic therapies. Select service members who have been diagnosed with post-traumatic stress disorder or traumatic brain injury may be eligible to receive a waiver from Defense Sec. Lloyd Austin to allow them to take part in the studies.

The FDA last month also announced that a joint approach of talk therapy and midomafetamine, or MDMA, would receive a fast-track review of six months, instead of the normal 10 months, given the potential of the therapy. The FDA provided a target date of Aug. 11 to conclude its evaluation and decision.

Results from studies on MDMA and other psychedelics have proven promising. The FDA designated MDMA as a “breakthrough therapy” for treatment of post-traumatic stress disorder in 2017. In 2019, psilocybin to treat anxiety and depression received that designation.

A second multi-site, phase III trial by the Multidisciplinary Association of Psychedelic Studies found that more than 86% of participants who received the MDMA-assisted therapy experienced “clinically meaningful” improvement in their symptoms 18 weeks after starting the trial.

Greater than 71% of participants who were administered MDMA-assisted therapy also no longer met the diagnostic criteria for PTSD at the end of the study, compared to little more than 46% of participants given the placebo plus therapy.

Zamone “Z” Perez is a rapid response reporter and podcast producer at Defense News and Military Times. He previously worked at Foreign Policy and Ufahamu Africa. He is a graduate of Northwestern University, where he researched international ethics and atrocity prevention in his thesis. He can be found on Twitter @zamoneperez.

Read the full article here

Related Posts