VA funding first psychedelic-assisted therapy study since the 1960s

SALT LAKE CITY — The U.S. Department of Veterans Affairs is planning to study the effects of a psychedelic drug on veterans as the regulatory landscape behind psychedelic treatment shifts.

The study, which is affiliated with Brown and Yale universities, is meant to understand the effectiveness and safety of MDMA — technically called 3,4-methylenedioxymethamphetamine and commonly referred to as ecstasy — on veterans with post-traumatic stress disorder and alcohol use disorder, according to a press release sent Tuesday.

While there have been small studies at VA facilities using external funds, this is the first time the VA has funded a psychedelic-assisted therapy study since the 1960s, the release says.

“I think one of the challenges with PTSD or trauma exposure is we try to fit it into a nice neat box,” said Dr. Steve Sugden, the Utah Psychiatrist Association president and a brigade commander in the U.S. Army Reserves. “Unfortunately, people just don’t respond well always to the nice, neat box approach.”

There are over 127,000 veterans in Utah, according to the VA’s 2023 report, on top of an estimated 16,000 active duty National Guard and reserve members. PTSD among military members is higher than the general population, with around 7% of veterans reporting having it at some point in their life. If deployed, that number increases significantly, according to VA data.

Those who were part of operations Iraqi Freedom and Enduring Freedom report PTSD levels of 29%.

How PTSD is treated

The first line of treatment for PTSD is a class of drugs called selective serotonin reuptake inhibitors, commonly called SSRIs, and therapy that works to “integrate (a patient’s) experiences of the past,” Sugden said.

“The therapy, the medications work for many people,” according to Sugden. Someone experiencing symptoms of PTSD may find themselves locked into extremes between a fight-or-flight trauma response and the opposite, where they freeze and can’t react or experience emotion.

“The window of tolerance is that space between where the body is in hyper reaction and hypo reaction,” Sugden says. That window is what he and other providers work to expand so that patients can establish for themselves a lifestyle more resilient to stress — exercise, sleep, improved connectedness, less substance use, and more.

For some, the medication and therapy do not seem to work. According to one study, some engaged in trauma-focused psychotherapy, the gold standard treatment for PTSD, have continued symptoms and drop out of therapy. SSRI medication does not work for an estimated 35% to 47% of people, the study says.

“A lot of times, these individuals are going to struggle,” Sugden said. “They struggle with acceptance, they struggle with relationships, they struggle with any type of way of trying to slow down the brain enough where they can have this better balance in their lives.”

Oftentimes, those with PTSD turn to substance abuse. “Many individuals have recurrent substance use and struggle to maintain long-term sobriety because their trauma symptoms have not been adequately treated,” he said.

“However you kind of slice it, the two of those really go hand in hand,” Sugden said. “They’re not finding balance, and so it’s just easier just to go to numb.”

MDMA and regulators

MDMA is currently classified by the Drug Enforcement Administration as a Schedule I substance with “no currently accepted medical use and a high potential for abuse.”

In 2017, MDMA-assisted therapy for PTSD received a Breakthrough Therapy Designation from the Food and Drug Administration, and a new drug application from Lykos Therapeutics was fast-tracked with a priority review in February.

That review ended in disappointment for the company, however. In June, an FDA psychopharmacologic drugs advisory committee voted 10-1 against recommending approval of the drug, in combination with therapy, due to concerns about the phase 3 study design and potential health risks. Approval of the drug-therapy combination was officially denied in August.

Policymakers, clinicians from the VA, scientists, and others met in Denver in September to “assess the state of existing scientific evidence regarding psychedelic-assisted therapies,” coming away with the recommendation that the VA begin funding its studies, according to a press release.

A grant of $1.5 million was awarded over five years for the first study, the release says, scheduled to begin in 2025 at the Providence VA Medical Center in Rhode Island and the West Haven VA Medical Center in Connecticut.

The study of psychedelics within the Department of Defense has also been authorized by the National Defense Authorization Act for fiscal year 2024.

MDMA and therapy

“I think that they’re trying to decrease the stigma behind seeking this as an alternative therapy,” Sugden said, adding that what is being considered is a very regulated amount, “a fraction of what is used in a nonregulatory state” in the ’60s and ’70s.

Psychedelics are “potentially part of a solution; they are not the whole solution,” Sugden said. “I think it gives us another armament; it’s another arrow in the quiver.”

He says therapy is critically important in the equation of MDMA-assisted therapy treatment. “Those who have done the research on this, we all talk about (therapy) being almost the most important part of it,” Sugden said.

Currently, there are serious concerns about increased access to the drug if it is reclassified to a lower schedule and the resulting abuse that could occur. Self-medicating with psychedelics or any other unprescribed substances is highly discouraged by providers. Shortcuts could become commonplace in what is an hours-long process with highly trained facilitators during studies.

Essentially, much more research must be done on expanded population subsections, including active military and veterans.

If a veteran were to walk into the VA tomorrow presenting symptoms of PTSD, it is highly unlikely they will be treated with MDMA and therapy, according to Sugden. But five years down the road, it might be a different story.

“The analogy I like is: It provides the scaffolding around the remodel,” Sugden said. “In the end, if it makes it easier for a person to try to engage in making the lifestyle changes. I think that’s phenomenal.”