For U.S. veterans, their families, and the mental health professionals working with them, the stakes have been high for decades as suicide rates in this population remain well above those for nonveterans.
In 2018, between 11 and 20% of veterans who served in Operation Iraqi Freedom and Operation Enduring Freedom were diagnosed with posttraumatic stress disorder (PTSD). After psychotherapy, up to two-thirds of veterans will keep that diagnosis, and between 20 and 40% will drop out of treatment courses.
Psychedelic-assisted psychotherapy has started changing treatment options for therapists and researchers working to support veterans with mental health conditions. Phase 3 clinical trial results of MDMA-assisted therapy for PTSD have been so promising, with 68% of participants experiencing remission, that the FDA granted the treatment and protocol Breakthrough Therapy designation. Phase 3 clinical trial results showed that “compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities,” according to an article published in Nature Medicine in May.
Encouraged by these results, an increasing number of researchers across the country are working with Veterans Administration medical centers to create and deploy protocols for psychedelic therapy, including MDMA, psilocybin and ketamine. Many of these programs use the protocol for MDMA-assisted psychotherapy developed by the Multidisciplinary Association of Psychedelic Studies (MAPS) as a model.
Slowly gaining momentum
This is not yet happening through the entire VA system. VA doctors, administrators, and support staff note that each center is different and are all quick to point out that “if you’ve seen one VA, you’ve seen one VA.” MDMA and psychedelics remain classified as Schedule I drugs and are illegal at the federal level. Bipartisan support for these therapies mean they could be rolled out en masse by 2024 or even sooner, following FDA approval.
MAPS is expecting FDA approval for their MDMA-assisted psychotherapy in 2023. But until then, researchers working with several local VAs are making moves, stepping tentatively but optimistically into psychedelic medicine to offer treatments. The programs and initiatives they’re building share key features, including a revolutionary way of providing therapy that comes with its own challenges and training components for practitioners entering the field.
“One big issue with the VA is that they still think this is a Western model,” says Jonathan Lubecky, Veterans and Governmental Affairs Liaison for MAPS, and a participant in their Phase II MDMA trials. “The sense is that ‘We’ll look at this when it’s FDA approved, like with every other drug.’ But they don’t fundamentally understand the ways this is different.” He points to the MAPS protocol used for sessions and training therapists. The protocol emphasizes the importance of therapy as an integral part of the treatment process and certification requirements for therapists.
The fact that people are even thinking about these challenges, Lubecky points out, is a major shift in the way these treatments are being considered. “Four years ago it was a different story,” he says. “People hadn’t heard about it and didn’t know about it. Media coverage of psychedelic trials has absolutely helped. The publication of peer reviewed academic pieces has helped to educate people, but it was only maybe two years ago that I started hearing, ‘As soon as it’s approved we’ll start doing it.’”
Focus on local VAs and vets
High-profile collaborations between VAs and partner institutions have made headlines recently. One such program is Dr. Rachel Yehuda’s Center for Psychedelic Psychotherapy and Trauma Research at the Bronx’s Mount Sinai Health System. Its two-pronged goal is to offer veterans MDMA-and psilocybin-assisted psychotherapy for the treatment of PTSD (with the intention to eventually expand to other compounds) – and to train therapists “in anticipation of FDA approval.”
In Portland, Oregon, Dr. Chris Stauffer, Assistant Professor of Psychiatry at the Oregon Health and Science University, and Director of the SNaP (Social, Neuroscience, and Psychotherapy) Lab, will begin recruiting veterans diagnosed with PTSD for an MDMA-assisted group therapy study early in 2022.
In another corner of the U.S., the Texas legislature passed H.B. 1802 in June, supporting Baylor College of Medicine, the Texas Medical Board, and the state’s Health and Human Services Commission to conduct a clinical trial on psilocybin-assisted therapy for veterans. That the study is happening at all showcases the bipartisan support for the research, and for exploring novel treatments for people struggling with stress and trauma-related mental health challenges.
The significance of this bipartisanship isn’t lost on Dr. Lynnette Averill, an Associate Professor at Baylor and the Clinical Director of the Emerge Research Program. The program is jointly housed at Baylor and Yale University, where Averill maintains a faculty appointment. Averill notes that the bill “flew through the House and Senate with almost unanimous support… and a lot of interest and conversation.” She is hopeful that patient enrollment will begin by next summer.
The Texas legislation has two parts. It calls for a “clinical trial on the therapeutic efficacy of psilocybin in the treatment of treatment-resistant post-traumatic stress disorder in Veterans.” It also commissions a comprehensive literature review regarding the safety and efficacy of MDMA, ketamine and psilocybin for PTSD, and the access veterans have to these treatments. Researchers will then compare the efficacy of these treatments to current options. Dr. Averill is exploring sources of funding a possible MDMA arm of the trial.
Averill’s team at Baylor will also head up the clinical trial with the Houston VA hospital, as the bill stipulates the study should be done “in partnership with a military hospital or a medical center that provides medical care to veterans.” The funding given to Baylor will be overseen by the State Department of Health and Human Services.
Averill, who clarified that she was not speaking on behalf of the VA or Baylor, previously worked in ketamine trials at the Yale and the National Center for PTSD-Clinical Neurosciences Division. She also completed a training in the MAPS’ protocol for MDMA-assisted psychotherapy. Averill moved to Texas in August, 2020 to build a research program focused on psychedelic medicine and assisted therapy.
“I serendipitously stumbled on the Texas bill,” says Averill, who reached out via LinkedIn to state representative Alex Dominguez, the bill’s chief sponsor, after she saw his post in support of psychedelic medicine for veterans with PTSD. “I had never looked at the homepage of LinkedIn before then,” she says. “I reached out because that’s what I wanted to do and to say kudos. I wanted to know the investigators they were working with.”
After an initial conversation, we “very quickly formed what we fondly called the Texas Dream Team,” Averill says. “I was in touch with Amber and Marcus Capone, the founders of Veterans Exploring Treatment Solutions, which started funding veterans to go to psychedelic-assisted treatment programs after Marcus had a life-saving experience.” The couple is based in Texas.
The Texas bill shifted Averill into a new area: policy and advocacy work. She is also involved with current legislation in Pennsylvania, and she sits on the Connecticut Psilocybin Study Workgroup created through that state’s legislative process. She notes that she’s a part of several other state- and federal-level conversations that are in motion.
Bipartisan support for psychedelic research
Texas and other Republican-majority states are key to these therapies becoming widely available, says Lubecky. “The psychedelic movement needs Dan Crenshaw [R-Texas] far more than it needs AOC [Alexandria Ocasio-Cortez, D-New York],” he says. He adds that Crenshaw sponsored a congressional bill to require the Department of Defense to fund research into these treatments in Texas. “It’s the first piece of causative psychedelic legislation in U.S. history, or at least in the past 60 years,” he explains. Although the bill didn’t make it out of committee, Lubecky notes that it was because of disagreements over details of the process rather than the bigger picture. “Even if Democrats lose the House in 2022, we can still move things forward,” he says.
“There’s broad bipartisan support in the veteran community,” says Stephen Apkon, a filmmaker and cofounder of Reconsider, pointing to the bipartisan House Appropriations Bill sponsored by Crenshaw. “There are some very apparent efforts within certain VAs around psychedelics, in Portland, with Dr. Yehuda in the Bronx, in San Francisco…. What we’ve learned is there’s significant interest from many VAs around the country. This is becoming more normalized.”
A recent Veterans’ Day forum convened by Reconsider and Horizons brought many of these voices together, focusing on psychedelic-assisted therapy for veterans that featured speakers including Averill, Yehuda, Stauffer, and Jesse Gould, founder of the Heroic Hearts Project. “We send millions of men and women to do our bidding in the world, and many come back with challenges,” Apkon noted as he opened the forum. “What is our responsibility in making sure they have an opportunity to heal?”
A paradigm shift inside the VA
Averill notes that veterans have been organizing and advocating for these interventions, and now the VA – the largest healthcare institution in the country – is assessing their challenges and benefits as it considers how to roll them out. “They’re very big questions with no easy answers,” she says.
According to Averill, federal leadership of the VA will likely take a page from local VA healthcare systems to assess at least some of these factors. “It’s a question of when rather than if,” Averill says. “Because creating these kinds of processes and infrastructure really does take time, I think a lot of groups and individuals – both very large-scale, like the VA, as well as other healthcare systems, even smaller-scale, independent providers – are starting to think about what this would look like for their clinics. How do we make scalable interventions? How do we address access and equity?”
Other questions to be addressed include where treatment rooms might be located within VA buildings, and how to outfit them for a therapeutic experience.
“This is a complete paradigm shift from our usual mental health protocols,” Averill explains. “Two therapists for eight hours a day for one patient is not something that’s really feasible within the healthcare system as it is right now.” She sketches out other challenges, including deciding on pricing and insurance coverage.
Other considerations include protections for Indigenous cultures and sacred practices. “What’s so unique about some of these plant and animal-based medicines is that we haven’t really dealt with this sort of thing before, where we’re taking something that has been used for millennia, saying it’s novel and new, and bringing it into this other context,” Averill says.
For Averill, Texas, which has a large and diverse veteran population, is the perfect place to launch this study. “Diversity is an important piece of this,” she notes, pointing to the fact that much of the research in the psychedelic space has historically been very white, despite the fact that marginalized groups are at greater risk of exposure to stress and trauma. “It’s critical that we have research and evidence that explores what these interventions look like for everyone else.”
As with other clinical trials and research in this field, therapists will be trained in a protocol similar to the one MAPS developed for MDMA-assisted psychotherapy, with a focus on set and setting, and integration sessions with a therapist. Therapists will also need to have experience working with trauma.
The Texas study is one of the first to receive state funding. Financial support for the other VA studies has come primarily from MAPS and private-sector foundations, including a multiyear Parsons Foundation Grant for Dr. Yehuda’s program.
New treatment protocols and special trainings could be more cost-effective than current approaches. A 2014 article from the National Center for Biotechnology Information notes that the cost of PTSD treatment for veterans has been steadily rising, costing $2.7 billion between 2007 and 2010. Lubecky of MAPS estimates that the federal government has spent $17 billion on compensation and pensions for disability related to PTSD since 1985, not including costs for additional mental health support and treatment for related issues like addiction. “The cost of this therapy would be minimal,” he says. “Even if we don’t have therapists in-house until we do more training, it would cost less to do this at the VA than they spend on medications for a year.”
Lubecky is optimistic that “within 24 months we’ll have a piece of legislation about funding psychedelic medicine” for veterans at the federal level. He suggests that this funding could come from the National Institute of Health, the VA, or the Department of Defense. “If it’s not a full bill, it could be language inserted into a bigger bill. There’s a lot of interest in doing something.”
High Stakes, Shared Trauma for Vets
The stakes are high for veterans and their support networks. The Reconsider team has hosted veterans’ gatherings, holding space for conversations around this topic. “One thing that came out of the first gathering is that this isn’t solely about the suffering of the veterans,” says Apkon. “There are programs addressing it in the underground and VAs are looking at it, but it affects families, spouses, children, generations, communities, and the nation. That trauma is shared. How do we address that as a community?”
“There are people who just want to make this work and wonder what the problem is,” says Averill, who adds that the U.S. loses one person to suicide every 11 minutes. “I get that frustration, and have a little of it myself. We must also consider how we are going to continue meeting the ongoing patient need while trying to train therapists in a new intervention. These are huge questions, and there are no really easy, straightforward, inexpensive answers.”
While the route to offering these therapies is complex, change is underway. “People are looking for other people to understand the struggles they’re having in different VAs and Veterans’ communities in general,” says Apkon. “They want to work together to problem solve, and partnerships are happening within and outside of the VA. A lot of veterans talk about being on a team that shares purpose and meaning. That’s the sense you feel when you’re engaged in this work with this community – that this is an enormous service to the country.”