Brain trauma affects millions. Learn about traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) and how they impact civilians and Veterans.
Cohen Veterans Bioscience is a non-profit 501(c)(3) biomedical research and technology organization dedicated to advancing brain health by fast-tracking precision diagnostics and tailored therapeutics.
Our approach is to build enabling platforms with strategic partners and to adopt a team science approach to fast-track solutions in years, not decades.
The types of compounds referred to as psychedelic compounds has expanded in popular culture. In general, the term refers to a group of substances that can produce temporary changes in a person’s mood, thoughts or perceptions of reality. They can also produce temporary changes in our senses, altering the way people see, hear, taste, smell or feel.
Psychedelic compounds come in many different forms, ranging from chemicals produced in a laboratory such as MDMA to natural compounds derived from plants, animals and fungi such as psilocybin. Researchers generally categorize the different compounds based on how they act in the brain.
Below are the basic categories of psychedelic compounds and some examples of each that are now being researched for their treatment potential:
Psilocybin (4-Phosphoryloxy-N,N-Dimethyltryptamine): Psilocybin, sometimes referred to as “magic mushrooms,” is a chemical compound found in certain mushrooms that grow in the United States, Mexico and South America. It is one of the most highly researched psychedelic compounds and is being studied as a potential treatment for variety of conditions including depression (both TRD and MDD), PTSD, AUD, anorexia nervosa and obsessive-compulsive disorder.
LSD (D-Lysergic Acid Diethylamide): Commonly referred to as “acid,” LSD is a clear or white, odorless, lab-made (synthetic) substance derived from lysergic acid, which is found in fungi that grow on rye and other grains. LSD is being studied as a treatment for conditions such as cluster headaches, attention deficit hyperactivity disorder (ADHD), and GAD.
DMT (N,N-Dimethyltryptamine): DMT is a chemical compound found in plants native to the Amazon rainforest. DMT is often consumed as a tea, known as ayahuasca. DMT can also be synthesized in a lab. DMT is being studied as a treatment for many conditions including TRD, bipolar disorder, and AUD.
Ketamine: Ketamine is a chemical compound used to induce anesthesia during surgery mainly in animals. A derivative of ketamine, called esketamine, has been FDA-approved to treat TRD since 2019, and both ketamine and its derivatives are being further studied as a treatment for conditions such as AUD, MDD, and acute suicidal ideation and behavior.
MDMA (3,4-Methylenedioxymethamphetamine): MDMA, also known as “ecstasy” or “molly,” is a lab-made (synthetic) drug that has some effects similar to stimulants such as methamphetamine in addition to producing psychedelic effects such as altered visual perceptions. MDMA is the furthest along in the FDA approval process, with advanced clinical trials in PTSD completed and being prepared for FDA review. MDMA is also being investigated as a potential treatment for other disorders, including eating disorders (anorexia nervosa and binge-eating disorder) and autism spectrum disorder.
Ibogaine: Ibogaine is a chemical compound that comes from the bark of certain plants, including the iboga shrub, which is used in religious ceremonies in Western Africa. While ibogaine does have psychedelic properties, it affects a different spectrum of brain activity than the other listed psychedelic drugs or dissociative drugs. Ibogaine is not as widely studied as the other compounds described and when it is, it is usually investigated in opioid withdrawal syndrome or AUD.
Why are psychedelic compounds now being considered as a potential treatment for brain disorders such as PTSD and depression?
Psychedelic compounds have been used for centuries in cultural and religious ceremonies. Some psychedelic compounds, specifically, LSD, received initial attention as a potential treatment for several psychiatric disorders in the 1940s. In the 1960s, the use of these drugs moved outside of research labs and into the public and became associated with both the counter-culture and concerns of abuse. This led to LSD and other psychedelic compounds without any proven medical use becoming regulated by the Drug Enforcement Administration (DEA) as Schedule I in the 1970s.Being categorized as Schedule I adds several time- and cost-intensive hurdles to clinical research, and, as such, the investigation of these compounds as potential treatments practically stopped.
However, the urgent need to identify better therapies for disorders with high rates of treatment resistance such as TRD and PTSD, combined with early promising results from small studies largely led by foundations, has fueled renewed attention on these compounds, including from the pharmaceutical industry. This research is still in the early stages. As of July 2021, there were only 14 published studies of classical psychedelics, enrolling a total of 315 participants, most without the expected controls that allow regulators to know whether the compound works. In 2022, the publication of two additional studies with more rigorous designs demonstrated that the field is taking this potential category of treatment seriously.
In order to understand their potential as a therapeutic, we need more large clinical trials conducted with rigorous scientific standards using guidance provided by the FDA.
Why/how are psychedelic compounds challenging to study?
Psychedelic compounds are inherently more challenging to study with the same rigor as other therapeutics. Because of these challenges (listed below), there are still outstanding questions related to the safety and efficacy of these compounds, as well as to the durability of their clinical effects. In addition, due to the limited number and narrow population studied to date, we do not yet know who the appropriate candidate patients for successful use are. Further, because these potential treatments are incredibly resource intensive, many questions remain on the equitable access of these treatments for all those who need them, regardless of economic means, as well as whether and how they will be covered by insurance. Finally, quality clinical data will help move forward the entire field of psychiatric disorder research.
Below are five issues that clinical trials studying psychedelic compounds must overcome:
Psychedelic trials are difficult to blind. Psychedelic compounds produce extraordinary subjective reactions that are well-known (and expected) by the trial participants. This is called the “set” or mindset issue. In addition to the mindset people have coming into the clinical trials, participants are often required to participate in pre-therapy sessions that prepare them for what they will experience. This increases their expectation of an effect, makes it even clearer when they are not in the study arm getting the psychedelic, and further challenges the ability to distinguish a drug effect from a “placebo” effect.
“Setting” refers to all that’s going on in your immediate environment during the psychedelic treatment session, such as the people around you and their behaviors, the type of furniture in the room, whether there is music playing, and even the smells and lighting of the room. Clinical trials need to determine how the environment in which the individual takes the compound enhances or detracts from the effects of the drug itself.
Many of these compounds are being developed as tools to enhance the effectiveness of psychotherapy. For example, some compounds have a capacity to induce an altered or opened sense of self and relatedness to others, which may enhance the psychotherapy experience by increasing trust and openness. Other compounds are thought to increase plasticity, potentially facilitating the uncoupling of fear from the traumatic memory during trauma-focused psychotherapies. For those compounds where the psychedelic therapy is proposed as enhancing the effect of psychotherapy, the FDA will have to consider how they will label a compound that enhances a type of therapy that they do not regulate, i.e., psychotherapy. This also emphasizes the need for the FDA to understand what the drug effect is apart from the psychotherapy effect. In addition, the DEA has designated many psychedelic compounds as Schedule 1, so there are limitations as to who can study them and under what conditions, which reduces the amount of research into these compounds compared with non-Schedule 1 compounds. With fewer studies, it makes evaluating the true effect of these compounds based on a limited number of and relatively small studies very challenging.
A well-designed, regulatory-quality study should determine whether the subjective effects are a necessary part of the “mechanism of action” or whether compounds can be developed that have the same potential effects without the risk of hallucinations, dissociation, or the need of multiple therapists and hours of being watched in a clinic during the administration period. Some drug development companies are specifically developing drugs that act on the same pathways in the brain but do not produce the hallucinations or other effects typically associated with psychedelic compounds.
Many patients with intractable PTSD will likely have previously been on or currently be on drugs with an overlapping mechanism of action such as SSRIs or SNRIs. For some people, if SSRIs or SNRIs were not effective for a patient, then the expected effect of a psychedelic that also works through the serotonergic system may not be as great. In those that did see some benefit from SSRIs or SNRIs, long term use of serotonergic drugs can actually change how the body responds to serotonergic drugs and thus, psychedelic compounds may not be as effective for those people. From a safety perspective, there is also the risk of inducing serotonin syndrome (with symptoms ranging from mild, e.g., agitation, tremor, to more serious, e.g., seizure, vomiting) by using more than one of these serotonergic drugs at a time.
CVB's position regarding research of and advocacy for psychedelic compounds
Research of Psychedelic Compounds
Cohen Veterans Bioscience is a non-profit 501(c)(3) biomedical research and technology organization dedicated to advancing brain health by fast-tracking precision diagnostics and tailored therapeutics. CVB is committed to improving the lives of people affected by trauma-related and other brain disorders through advancing research into all therapeutics that demonstrate potential to treat the invisible wounds.
Early clinical research on the use of psychedelic compounds and psychedelic-assisted therapy to treat the invisible wounds has shown great promise, but the number of clinical trials involving these compounds is small and relatively few patients have been included in the studies. CVB advocates for rigorous biomedical research and the comprehensive evaluation and assessment of psychedelic agents’ effectiveness, safety and best candidates for treatments.
CVB promotes policies and legislation that will positively impact Veterans, first responders and all Americans in need of new solutions for debilitating conditions such as PTSD by advancing research into the potential of psychedelic compounds.
To expand clinical research into psychedelic compounds to address critical gaps in the scientific knowledge and provide conclusive evidence on the safety and effectiveness of psychedelic therapies. These studies should employ rigorous research designs and include larger, more diverse populations.
To compel the FDA to develop critical clinical trial guidance that addresses the unique challenges of designing and carrying out clinical trials with psychedelic compounds and improves regulatory certainty for those seeking to develop safe and effective therapies for these disorders.
To work with the DEA and other regulatory agencies to make it easier for qualified researchers to work with and conduct studies using psychedelic compounds to further understanding of how these drugs work in the brain.
Cohen Veterans Bioscience is driving the development a Brain Trauma Blueprint to guide a next generation of diagnostics and therapeutics across Traumatic Brain Injury and Post-Traumatic Stress Disorder.
The theme of the second State of the Science Summit was Paths to Treatment for Traumatic Brain Injury(s) with a focus on the taxonomy and nosology of the chronic sequelae, challenges and opportunities in clinical practice and development, and etiology and mechanism of persistent symptoms1. As measurement tools advance, research has been able to focus on different types of injury, beyond the mild, moderate, and severe classifications. To augment and support the many efforts across fields and organizations over the past decade, we aim to map a consensus blueprint to drive translational science for TBI.
The resulting recommendations create actionable research priorities to be prioritized across the research ecosystem.
Proceedings from the 2019 State of the Science Summit:
Fostering Collaboration to Advance Solutions for Traumatic Brain Injury (TBI)
Cohen Veterans Bioscience is driving the development a Brain Trauma Blueprint to guide a next generation of diagnostics and therapeutics across Traumatic Brain Injury and Post-Traumatic Stress Disorder.
In 2019, we hosted our second State of the Science Summit (SOSS) with over 100 thought leaders to foster consensus around potential paths to treatment for TBI. The goal was to define TBI beyond the typical classifications of mild, moderate or severe, in order to more clearly describe underlying disease mechanisms. The Summit focused on the chronic sequelae of TBI and aimed to identify current knowledge gaps in the etiology and mechanisms of persistent TBI symptoms.
The resulting recommendations create actionable research priorities to be prioritized across the research ecosystem and will be rolled out in the next few months.
Rationale for the 2019 State of the Science Summit
The Brain Trauma Blueprint is an initiative aimed at accelerating an era of personalized medicine for survivors of brain trauma through a series of invitation-only State of the Science Summits (SoSS). With few FDA-approved treatments for long term neuropsychiatric sequelae of traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD), the development of targeted therapeutics will require clearer understanding of their biological underpinnings. By fostering collaboration across the broader stakeholder community, we will enable translational research gaps to be bridged and achieve solutions sooner for those suffering from trauma-related brain disorders.
Each SoSS includes a review of the landscape drafted by a Scientific Planning Committee, which comprises of key thought leaders with deep expertise in trauma-related brain disorders. The first of the two-day meeting consists of presentations and working sessions discussing the state of the field and major research gaps. The second day includes time to define, refine, and prioritize research gaps.
The trauma-related brain disorder research community has repeatedly lamented the lack of mechanistically targeted therapeutics for TBI. Through breakout and group discussions, consensus around knowledge gaps and strategies to leverage the combined intellectual resources of the scientific and clinical communities will lead to the generation of research priorities that will overcome the gaps and hasten the development of precision-therapeutic options for individuals living with trauma-related brain disorders. This requires advancing knowledge on molecular mechanisms of injury, more refined methods of diagnosis, subtyping patients to better select potential treatments for their disease mechanism, and successfully advancing through clinical trials. A blueprint of past and current research activities can help guide development efforts and accelerate the progression towards a new generation of precision diagnostics and targeted therapeutics.
Historical Context
TBI is currently classified as mild, moderate, or severe and is managed based on a level of consciousness, irrespective of the heterogenic pathophysiology leading to that severity score. The ability of these classifications to predict subsequent patient burden, including neurodegenerative trajectory, is not well understood and can be complicated by subjective measurement techniques, fluctuating presentations and comorbid disorders. Indeed, despite initial hospitalization and inpatient rehabilitation services, about 50% of people with TBI will experience further decline in their daily lives or die within 5 years of their injury; in cases of mild injury where patients often fail to seek help, delayed sequelae may arise leading to cognitive decline or other functional deficits.
While great strides have been made in managing patients after acute brain injuries, particularly those classified as severe, the field is increasingly looking to address the chronic sequelae of mild brain injuries by focusing on identifying the molecular mechanisms underlying the long-term symptoms using animal models2. This requires identifying gaps in our understanding of the presence, presentation, trajectories, and underlying mechanisms of the long-term effects. By leveraging the power of leaders across the brain health spectrum and strengthening the cohesion of the scientific, clinical and patient communities within TBI, the community will have a roadmap to identify the underlying biological processes across TBI injury types, improve patient biotyping and better advance clinical trials. This will translate to precise diagnostics and prognostics for those suffering from brain injuries and ultimately reduce patient burden.
The inaugural State of the Science Summit (SOSS) focused on Diagnosis of Trauma-Related Brain Disorders with a major focus on Post-Traumatic Stress Disorder.
Based on a prioritized list of foundation translational research gaps from the Brain Trauma Blueprint Executive Committee, the first summit explored the state of the science in diagnosis of trauma-related brain disorders. During the summit, thought-leaders will moderate sessions addressed the issues with defining these disorders by their symptom presentation and discuss the need to create a new taxonomy of disease for these conditions enabled by deeper understanding of the underlying biology of post-trauma sequelae and novel technological advances.
Attendees worked to build consensus around knowledge gaps and discussed strategies to move the field forward by leveraging the combined intellectual resources of the full community. The summit served as a launchpad for ongoing Working Groups to develop evidence-based strategies on how to fill those gaps, identify new gaps as others are filled, and disseminate these findings back to the community at large.
Every year, millions of Americans, including Veterans, active military, first responders and public safety personnel, experience traumatic brain injuries and their devastating chronic effects, including suicide. Yet, in 2022, we still have no FDA-approved TBI diagnostics or treatments.
Through prior BTB State-of-the-Science Summits we worked with the research community to identify and publish consensus challenges and a path ahead. The resulting TBI Precision Research Roadmap maps out priorities for accelerating a first generation of precision diagnostics and targeted treatments for brain trauma.
During the inaugural Action Summit, the TBI leadership community discussed priorities and a path to foster collaboration across the broader stakeholder community to achieve solutions sooner for those suffering from trauma-related brain disorders.
Together, we will empower all stakeholders to be informed and strategic architects through the Brain Trauma Blueprint.
Chair, Veterans Advisory Council Cohen Veterans Bioscience
KATHY LEE, MS, CRNP, ANP-BC
Director, Casualty Management Policy and Programs U.S. Department of Defense Warfighter Brain Health Program
JAMIE M. METCALF
Honorary Board Member David R. Metcalf Invisible Wounds Foundation
DANISH MUNIR
Founding Partner GrayMatter Capital
GRACE PENG, PHD
Program Director, Mathematical Modeling, Simulation and Analysis National Institute of Biomedical Imaging and Bioengineering, NIH
PETER PEUMANS, PHD
CTO Health Interuniversity Microelectronics Centre (IMEC)
MARY JO PUGH, PHD, RN
Professor/Career Scientist University of Utah / VA Salt Lake City
RACHEL RAMONI, DMD, SCD
Chief Research and Development Officer US Department of Veterans Affairs
DOUGLAS SMITH, MD
Robert A. Groff Professor Of Teaching And Research In Neurosurgery Perelman School of Medicine, University of Pennsylvania
ELISABETH WILDE, PHD
Associate Professor, Director of Research for Physical Medicine and Rehabilitation Baylor College of Medicine
TRISTAN WIMMER
Founder 22 Jumps
Highlights from the 2022 Brain Trauma Blueprint Action Summit
Announcing the TBI Action Alliance
CVB’s CEO & President Magali Haas, MD, PhD announced the development of the TBI Action Alliance, a public-private partnership alliance optimizing the capabilities of industry, academia, government, and other stakeholders to take action on the TBI Roadmap recommendations.
The coalition will support and advance a coordinated approach to accelerate the development and adoption of new solutions for TBI.
Beyond Hope to Action
Moderator:
Shannon Finn Connell, PhD, CEO, David R. Metcalf Invisible Wounds Foundation
Panel:
Frank Larkin, Chair, Veterans Advisory Council, Cohen Veterans Bioscience
Jamie Metcalf, Honorary Board Member, David R. Metcalf Invisible Wounds Foundation
Tristan Wimmer, Founder, 22 Jumps
The Summit kicked off with an emotional start as Veterans and individuals touched by suicide highlighted how the negative impact of suicide ripples through families and communities. They emphasized why we need to move quickly to identify objective diagnostics and tailored treatments for TBI to help prevent suicide. Only by working together can we address this urgent need.
Keynote: The Warfighter Brain Health (WBH) Initiative
Kathy Lee, MS, CRNP, ANP-BC, Office of the Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight
Ms. Lee presented an exciting new Department of Defense strategy aimed at unifying efforts to optimize brain health for military personnel. This included a call for collaboration across multiple government departments and other stakeholders across the public and private sectors to develop and implement a comprehensive brain health research strategy focusing on finding solutions for the debilitating effects of brain trauma.
Keynote – Building upon NRAP: Working together to solve well-defined problems efficiently
Rachel Ramoni, D.M.D., Sc.D., Chief Research & Development Officer (CRADO), Department of Veterans Affairs
Ms. Ramoni made the case that we must recognize TBI as a public health emergency. She also highlighted how data sharing and collaboration are key to advancing solutions.
Brain Trauma Blueprint Roadmap Recommendations
Brain Trauma Blueprint Scientific Steering Committee experts provided a report on the state of the science in TBI research, an output of a collaborative effort focused on identifying paths forward in disease burden, preclinical research, biomarker development, phenotypes, clinical trials and implementation science. View Publications
Capital to Opportunity
Danish Munir, Founding Partner, GrayMatter Capital
“The time for change is now.” Mr. Munir discussed potential investment areas in mental health care and technology, highlighting the link between mental and physical health and opportunities to drive telehealth, AI and machine learning advancements. His presentation emphasized the important role that venture capital can play in turning new discoveries into solutions and the need to explore innovative funding models.
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One pivotal component of CVB’s Blueprint Process is to take a leadership role in bringing together key stakeholders at a State of the Science Summit to survey the current scientific knowledge, identify knowledge gaps, and consider new clinical models and actionable research priorities that will inform funding efforts and accelerate the development of a new generation of precision diagnostics and targeted therapeutics.
After subject-matter experts document the research gaps, we develop an action plan outlining solutions and opportunities to advance research that will bridge the gaps, including needs for funding.
By fostering collaboration across the broader stakeholder community, we will advance solutions for people suffering from trauma-related brain disorders.
2018 State of the Science Summit: Post-Traumatic Stress Disorder (PTSD)
The inaugural State of the Science Summit focused on diagnosis of PTSD. During the summit, thought leaders addressed the issues with defining these disorders by their symptoms and discussed the need to create a new taxonomy of disease for these conditions.
Attendees worked to build consensus around knowledge gaps and discussed strategies to move the field forward. The summit served as a launchpad for ongoing working groups to develop evidence-based strategies on how to fill those gaps, identify new gaps as others are filled, and disseminate these findings back to the community at large.
2019 State of The Science Summit: Traumatic Brain Injury (TBI)
Our second State of the Science Summit hosted more than 100 thought leaders to foster consensus around potential paths to treatment for TBI. The goal was to examine the current classification system for TBI diagnosis in order to advance more precise diagnostics. The Summit focused on the chronic effects of TBI and identified the current knowledge gaps in the mechanisms of persistent TBI symptoms.
The inaugural Brain Trauma Blueprint (BTB) Action Summit held on October 18-19th 2022 at the Ronald Reagan Building and International Trade Center in Washington DC, convened national stakeholder groups across government, academia, foundations, industry, and individuals with lived experience, to plan to execute the TBI Precision Research Roadmap, through collective public and private action. Through the Action Summit, the TBI leadership community developed an action plan with specific priorities that the community must take to achieve solutions sooner for those suffering from trauma-related brain disorders.
Brain trauma is an acquired injury to the brain that can be caused by either physical trauma (traumatic brain injury) or a psychological experience (post-traumatic stress).
Post-traumatic stress disorder (PTSD) is a clinically diagnosed condition that develops in some people who have experienced a shocking, scary, or dangerous event.1 The associated stress of experiencing or witnessing this trauma can cause physical changes in the brain.
Traumatic brain injury (TBI) is defined as damage to the brain resulting from external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile.2
For both PTSD and TBI, the trauma can lead to changes in the structure and function of the brain that result in a variety of cognitive, physical, and emotional symptoms. Some of these symptoms may appear immediately after the traumatic event or brain injury, while others may be delayed, emerging months or even years later.
PTSD and TBI often coexist, and many of the symptoms of PTSD and TBI overlap. This can make it difficult to attribute the resulting symptoms to one disorder or the other and also can lead to misdiagnoses and delays in treatment. Both PTSD and TBI can greatly impact a patient’s health in terms of increased risk for other conditions such as cardiovascular disease, hypertension, hyperlipidemia, and obesity, as well as a number of psychological disorders such as depression, anxiety and substance use disorders.
Brain Trauma and Suicide
Both PTSD and TBI can increase the risk for suicide. Increased suicide risk is of particular concern among Veterans and service members. Studies by the Department of Veterans Affairs find that a history of TBI or PTSD is associated with a substantially increased likelihood of suicide attempts compared to those without the diagnosis — 1.5 and 2.8, respectively. For those with both TBI and PTSD, the likelihood of a suicide attempt is 3.3 times greater than for those with a TBI alone.
Studies among civilians also show a link between suicide and a history of PTSD and/or TBI.
Trauma can happen to anyone.
1/3
Up to 22
Tragically up to 22 American Veterans and service members die by suicide daily.
2/3
70%
In a global survey, 70% of respondents reported witnessing or experiencing a traumatic event.
Every 5 seconds, a man, woman or child in the U.S. suffers a traumatic brain injury.
Millions affected by brain trauma are still waiting for solutions
Despite the frequency of brain trauma, decades of promising research and billions spent on clinical studies:
There are no cures for brain trauma.
Patients are diagnosed based on subjective, patient-reported symptoms, and not in an objective way based on their unique biology.
We lack reliable, evidence-based treatments.
Our mission is to fast-track and advance solutions to diagnose and treat PTSD and TBI. No one who experiences brain trauma should have to suffer the effects for a lifetime.
The Relationship of Attention-Deficit/Hyperactivity Disorder With Posttraumatic Stress Disorder: A Two-Sample Mendelian Randomization and Population-Based Sibling Comparison Study
Plasma biomarkers associated with deployment trauma and its consequences in post-9/11 era veterans: initial findings from the TRACTS longitudinal cohort
Enhancing Discovery of Genetic Variants for Posttraumatic Stress Disorder Through Integration of Quantitative Phenotypes and Trauma Exposure Information
White Matter Hyperintensities Are Not Related to Symptomatology or Cognitive Functioning in Service Members with a Remote History of Traumatic Brain Injury
Comparison of Plasma Phosphorylated Tau Species With Amyloid and Tau Positron Emission Tomography, Neurodegeneration, Vascular Pathology, and Cognitive Outcomes
Cross-platform comparison of highly sensitive immunoassay technologies for cytokine markers: Platform performance in post-traumatic stress disorder and Parkinson’s disease
Prevalence of Cerebral Microhemorrhage following Chronic Blast-Related Mild Traumatic Brain Injury in Military Service Members Using Susceptibility-Weighted MRI
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