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What are psychedelic compounds?

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. 

Learn more about our brain trauma research

Advocacy for Psychedelic Compounds

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. 

Through the Coalition to Heal Invisible Wounds, CVB has three advocacy priorities: 

  1. 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.
  2. 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. 
  3. 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.
Learn more about CVB's advocacy efforts

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The Sponsorship Program provides non-government funding to support the projects outlined in the TBI Precision Research Roadmap to accelerate progress and results.

Your sponsorship will help us drive a new era of research for TBI that advances a first generation of FDA-approved diagnostics and treatments.

Sponsorship levels are based on total annual or combined (3 year) commitment for individual or multiple programs, projects or infrastructure efforts delineated by the Precision TBI Research Roadmap. Commitments are formalized through a Grant or Gift Agreement with Cohen Veterans Bioscience, subject to Alliance terms & conditions, and payments are made annually in accordance with commitment terms.

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About the TBI Action Alliance

The Challenge

Every year, millions of Americans, including Veterans, active military, first responders and public safety personnel, experience traumatic brain injuries and their associated devastating chronic effects, including suicide.

Yet, in 2023, we still have no FDA-approved TBI diagnostics or treatments.

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The Facts

  • TBI is broadly defined as an alteration in brain function or other evidence of brain pathology caused by an external force that can occur in traffic, at home, at work, during sports activities, and on the battlefield1.
  • Approximately 70 million individuals worldwide will suffer a traumatic brain injury (TBI) each year2.
    • Military TBI – TBI is the most common traumatic injury in the US military, affecting >310,000 service members between 2000-20153
    • Intimate Partner Violence – TBI has been associated with IPV in 19-75% of cases4,5
    • Geriatric TBI – the highest incidence of TBI occurs in older adults (ages 65 & over) associated with falls6
    • Childhood TBI – an estimated 475,000 children aged 0–14 suffer a TBI each year7
  • 5.4M Americans are living with a long-term disability due to a TBI
  • In 2015, the cost for direct TBI medical care in the U.S. was estimated at more than $50 billion per year8
  • By contrast, the annual investment by the NIH in TBI-related research programs = ~$185M based on 2021 reporting9
  • A history of TBI or PTSD has been shown to be associated with a substantially increased likelihood of suicide attempts compared to those without the diagnosis — 1.5 and 2.8, respectively10

What the TBI Action Alliance Will Do

Raise Awareness and Advocate for TBI Research

Raise Awareness and Advocate for TBI Research

By presenting a unified and powerful voice to policymakers, funders, scientists and others who support TBI research efforts, we can ensure our priorities become theirs.

Establish a TBI National Research Agenda

Establish a TBI National Research Agenda

Build a TBI Precision Research Roadmap and support scientific, regulatory and government policies that place TBI research at the top of the national agenda and ensure adequate funding and resources to execute it.

Put Patients at the Center of Research Endeavors

Put Patients at the Center of Research Endeavors

Engaging the Community in the establishment of the Research Roadmap and holding its execution accountable to the Community as well.

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Spark a New Era of Innovation for TBI Solutions

The nexus of need, capital and aligned research priorities will attract new innovative thinkers and foster the advancement of new innovative approaches for TBI.

Chart Progress

Chart Progress

We will track progress against roadmap milestones and report out to the Alliance membership progress of collective efforts.

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The Roadmap

Cohen Veterans Bioscience (CVB), a national, nonpartisan 501c3 non-profit research organization dedicated to fast-tracking the development of diagnostic tests and personalized therapeutics for brain health, established the Brain Trauma Blueprint – a framework for generating and executing precision research roadmaps.

Brain Trauma Blueprint Process

Through this framework, CVB has convened TBI Researchers and other stakeholders at State of the Science Summits to identify and publish consensus challenges and recommendations for TBI research.

The resulting TBI Precision Research Roadmap outlines the research projects & policies needed to accelerate a first generation of precision diagnostics and targeted treatments for TBI and also the systemic changes required to ensure that all those suffering from TBI can get access to these new innovations, and other support and care, they so desperately need.

The TBI Precision Research Roadmap focuses on 7 Lines of Effort:

  1. Injury burden – Identify the burden of TBI across all populations and injury severities as determined by incidence, prevalence, and long-term trajectories of patients suffering from TBI
  2. Disease models – Develop an array of translationally valid disease models (preclinical and computational) based on a biological understanding of trauma pathogenesis and disease phenotypes that support evaluation of novel therapies
  3. Precision Diagnosis – Identify, develop and validate diagnostic, prognostic and predictive biomarkers for TBI to develop first generation diagnostic tests
  4. Targeted Therapeutics – Validate therapeutic targets & fast-track a first-generation of TBI (wellness, device, digital, drug) therapeutics targeted to the right person at the right time
  5. Clinical practice implementation – Accelerate adoption of best practices, clinical practice guidelines, and precision therapeutic approaches to optimize brain health outcomes
  6. Translational Infrastructure & Enabling Technologies – Identify & address infrastructure, incentives, regulatory and technology gaps to advance the TBI roadmap
  7. Awareness & Advocacy – Place TBI at the top of the US Public Policy agenda and raise awareness to reduce stigma of brain injury, encourage treatment-seeking, and enable access and reimbursement of care

We believe that a different model is needed to achieve success – a model where we collaborate to identify the most pressing research gaps and work collectively to address those gaps and ensure our work is not done in isolation, but as part of a more coordinated effort with the right resources and the right focus on each of the Roadmap Goals & Objectives.

An Alliance that will deliver on the promise of precision diagnostics and targeted therapeutics with clear wins within 2-3 years.

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Join Us

We are at a crossroads of TBI Research. While there has been increased awareness and funding, we have not made enough progress.

The time is now to embark on a new model of research, where researchers, the government, industry and those with lived experiences come together to focus on achieving specific and measurable objectives that will transform the lives of people who suffer a TBI.

We ask that you join us in this critical fight for our Veterans and others who have suffered long enough and become a Member of the TBI Action Alliance.

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Sources / Citations

1 Manley, G.T. and Maas, A.I. (2013) JAMA 310, 473-474.

2 Haarbauer-Krupa J, et al. (2021) Epidemiology of chronic effects of traumatic brain injury. Journal of neurotrauma. 2021 Dec 1;38(23):3235-47.

3 Helmick et al (2015) Brain Imaging and Behavior. Sep;9(3):358-66.

4 Iverson, Dardis & Pogoda (2017) Comprehensive Psychiatry, 74, 80–87. doi:10.1016/j.comppsych.2017.01.007

5 Valera et al. (2018) Journal of Neurotrauma, 36,661–668. doi:10.1089/neu.2018.5734

6 Gardner et al. (2015) Journal of Neurotrauma, 35:889–906. doi: 10.1089/neu.2017.5371

7 Dewan et al. (2016) World Neurosurgery, 91:497-509.e1 doi: 10.1016/j.wneu.2016.03.045

8 Frieden TR, Houry D, Baldwiin G. (2015) Report to Congress on Traumatic Brain Injury in the United States: Epidemiology and Rehabilitation. Atlanta, GA: CDC 2015. https://www.cdc.gov/traumaticbraininjury/pdf/tbi_report_to_congress_epi_and_rehab-a.pdf

9 https://report.nih.gov/funding/categorical-spending#/

10https://pubmed.ncbi.nlm.nih.gov/21599727/

The goal of the 40Winks study is to evaluate and improve methods of measuring sleep at home, which may help inform the development of diagnostics and treatments that are user-friendly, cost-effective, and reliable.

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How It Works

  • Participants will be provided a wearable wrist device (Fitbit) and a bed sensor (Withings) which will be placed under your mattress.
  • With your iPhone, you’ll download the study app and use it to complete a sleep diary.
  • Over the course of two weeks, you’ll track, monitor, and share your sleep data via these devices.
  • Participants will be compensated up to $150 for their time contributing to the study.
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Digital health sleep dashboard

Why Participate

  • Your participation can help determine the best use of new technologies to measure sleep at home. These technologies may be used in the future to help improve the sleep of people suffering from brain disorders.
  • Using a sleep activity dashboard, you’ll gain a better understanding of your sleep patterns by tracking and reviewing your own sleep data.

Eligibility Overview

  • Healthy adult volunteers, or adults self-reporting insomnia
  • Willing to participate for two weeks
  • Male or female, 18-77 years of age, inclusive
  • Participants need a reliable connection to the internet and must be willing to use their own iPhone as prescribed
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About the Study Sponsor

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.

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Learn More About Clinical Trial Participation Opportunities

There are many different ways to find out about clinical research opportunities that might be of interest to you. Many doctors offices have brochures or advertisements about studies they are conducting or someone in their practice or hospital are conducting. A local study site might advertise on the radio or on the internet about their study. The sponsor of a study may have a website dedicated to informing people about the study. These websites may allow you to see if there is a study site near you.

Many patient advocacy groups also list available clinical studies on their websites. And finally, as all clinical studies of new treatments are required to be listed on a national registry, you can also search for your area of interest and “recruiting” or “not yet recruiting” at ClinicalTrials.gov.

Cohen Veterans Bioscience has several studies that are ongoing or about to start that you may be interested in learning more about.

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Suicide rates among Veterans are not improving.
We can and must do better.

Up to 22
Up to 22

Tragically up to 22 American Veterans and service members die by suicide daily.

300,000
300,000

Nearly 300,000 Veterans who returned from the wars in Iraq and Afghanistan are suffering from PTSD.

Veterans and service members need more treatment options.

Despite decades of promising research and more than $1.1 billion spent on clinical trials1, no new drugs for PTSD and TBI have successfully advanced to FDA approval. And the research pipeline for new devices and therapies is thin as many pharmaceutical companies have abandoned research into PTSD and TBI.

Complex problems require a new approach that embraces collaborative science conducted to the highest standards of quality and with an openness to share data towards a common goal.

About the Coalition

Co-founded by Cohen Veterans Bioscience, the Coalition to Heal Invisible Wounds brings together leading non-profit organizations seeking to advance a comprehensive research-focused advocacy agenda to address the invisible wounds of war—PTSD and TBI—as well as to address co-morbid conditions such as pain and substance use disorders, which are known to dramatically increase the risk of suicide among Veterans and service members.

Advocacy Priorities

The Coalition seeks to promote reforms, policies and meaningful research investments that will spur new research discoveries and advance a precision medicine approach for the invisible wounds of war.

Coalition Members

The ultimate goal of the Coalition’s advocacy efforts is to realize better treatments, improved quality of life, new cures, and a reduction in the rate of suicide among Veterans and service members.

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Contact

For more information about the Coalition to Heal Invisible Wounds and how to become a member, please contact our Senior Director of External Affairs, Dr. Chantelle Ferland-Beckham.

Dr. Chantelle Ferland-Beckham, Ph.D.
Senior Director, External Affairs
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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.

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.

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