With the excitement of the Super Bowl now behind us, it’s worth recalling another aspect of America’s most popular spectator sport: the many NFL players who face a lifetime of struggle with injuries from their years on the field. Traumatic Brain Injury is particularly common, a condition that’s also widespread among veterans. Another thing worth recalling: the growing body of evidence that suggests psychedelic therapy may help heal TBI. But funds for the research have been slow in coming.
That’s why the research program recently announced by Heroic Hearts Project to study the physiological and psychological effects of psilocybin ceremonies on veterans with TBI is a big deal. A partnership with Imperial College London and Beckley Retreats, the study is not only groundbreaking in its focus, but innovative in its approach. The program follows 40 vets from their intake process at a Jamaican psilocybin retreat center through a week of group healing activities that include two sessions with the psychedelic compound in cohorts of ten to twelve people each. ICL researchers will gather data that allows for insightful comparisons to the findings of clinical trials, a practice that is too rarely done.
Path to profits. There is a significant difference between this kind of observational study, which follows people in real world settings, and clinical trials, which are far more regimented. Clinical trials are meant to identify how a specific chemical affects a particular receptor in the body, in isolation from other factors. That’s a major reason why psychedelic clinical trials have patients take the drug accompanied by one or two guides in a controlled setting, like inside a doctor’s office or research facility. Of course, that’s very different from the common practice among indigenous cultures, where group journeys are the norm.
But the FDA requires it, because that’s their well trod method for determining whether a drug is effective and worthy of patent protection, which enables it to be monetized. For a psychedelic pharmaceutical company attracting investment, FDA clinical trials are the path to profits – though approval can be a decade away and cost north of a hundred million dollars. The financial incentive to make a compound into monetizable intellectual property also dissuades research into the effectiveness of psychedelics in the public domain, like psilocybin.
One company that has pursued a proprietary psychedelic TBI treatment is Wesana Health, led by Stanley Cup winner Daniel Carcillo. But unlike the Heroic Hearts program, Wesana’s focus has been on TBI from sports injuries, which differ enough from battlefield injuries that their protocols may be less relevant for vets. Still aiming to start their clinical trials, Wesana’s efforts can’t have been helped by the downturn in the psychedelic investment market that has seen its share price drop from over $3.50 eighteen months ago to about $0.035 today.
Treating TBI with ceremony. Jesse Gould of the nonprofit Heroic Hearts had been hearing stories from veterans who used psilocybin in the underground for emotional healing, and who then found that their TBI symptoms were diminished or entirely gone. Convinced that the potential is worth investigating, four years ago he began the fundraising effort that led to last week’s announcement. It took that long to raise the $100,000 necessary through grants and private donations.
“We decided to figure out what works and what doesn’t,” Gould said. “Oftentimes these treatments don’t have a commercial or economic viability. Beckley helped by providing the retreat center in Jamaica, that reduced our costs a lot. And we got the ethics approval through Robin Carhart-Harris’ lab at Imperial College London, which was first made possible by Amanda Fielding and the Beckley Foundation.”
The week’s program will be unsurprising to anyone familiar with psychedelic retreats in Peru or elsewhere, though there’s more therapeutic support than is standard. In the weeks leading up to the retreat, participants will receive individualized coaching to prepare. When they arrive, they come to a beautiful setting in nature – not a clinic – and take part in a group discussion that includes a sharing of intentions. The first medicine ceremony will be with three grams of psilocybin, there’s a second stronger one later in the week with five grams. In between they will be led in wellness practices, including breathwork, yoga, and mindfulness integration. There are also group therapy sessions to discuss what they went through, and to support one another.
The researchers will take standard metrics for PTSD and depression, as well as assessments to determine the level of brain damage, including EEG measurements at the beginning and end of the week.
Therapy outside the traditional model. Another difference from clinical trials: there’s no placebo. Every participant receives psilocybin. While that makes it more difficult to distinguish the specific drug effect, explains Grace Blest-Hopley, a research associate at Kings College London and research director of Heroic Hearts, “the mechanism of how these drugs work and how a placebo works are overlapping.” In effect, they will measure the participants’ belief in the medicine’s ability to help them heal. From a research perspective, she “recognizes [this] as both a constraint and a strength.”
Gould adds that “ceremony and singing go part and parcel with the experience. We like group therapy and other things that clash with the clinical trial approach. We feel confident that these things are effective, and that the psychedelic experience is not supposed to be reduced. It’s supposed to be expansive. With an observational study, we can get to a better level of understanding to provide safe treatment without having to go through all the rigors of the clinical trials.”
Parallel Models. FDA approval appears to be on track for MDMA and psilocybin treatments for PTSD and treatment resistant depression. But as more states join Oregon and Colorado to create frameworks for psychedelic therapies, studies like this one may provide the groundwork for healing practices to help those suffering from other conditions, like TBI among vets, that the traditional pharmaceutical model is not ready to address.
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