Psychedelic Research - A Tipping Point
We all remember the DEA, don’t we? Not exactly the friendliest when it comes to parties. But on July 22, 2022, something peculiar happened. They dropped their proposal from January of that year to classify five tryptamine-class psychedelics – 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT – under the most restrictive category, Schedule I.
The recommendation for this rule was originally made in 2012 by the US Department of Health and Human Services, based on small-scale misuse and similarities to existing hallucinogens as enough evidence for its classification. Even with the DEA acknowledging the need for a more recent "scientific and medical evaluation", this unexpected reversal may suggest a shift in the perspective towards psychedelic research.
A lot is happening around this issue, so let's sort it out.
Why the DEA Shifted on Psychedelics
This shift seems to be a response to an outpouring of public comments and hearing requests from scientists and pharmaceutical companies. The original rule was based on a 2012 recommendation, citing small-scale abuse and similarity to existing hallucinogens as the reason for the harsh classification. This drew quite a backlash, making the DEA do a double-take.
Psychedelics - Not Just for Parties Anymore
Over the last ten years, the potential of psychedelics for treating mental health disorders has gained recognition. From being used recreationally and having millions search the web for "are magic mushrooms harmful?" to being investigated for their therapeutic benefits, these mushrooms have come a long way.
As recognition of their legitimacy grows, the FDA has granted 'breakthrough therapy designation' to psilocybin and MDMA for resistant depression and PTSD, respectively. This, coupled with increasing interest from various therapeutics companies, has led to an estimated market value of over $8 billion for psychedelics by 2028. As such, the field has drawn interest from both public and private institutions.
New Players in Psychedelic Therapy
With increased funding pouring into research and patenting, institutions, such as Compass Pathways, are moving beyond 'classical psychedelics' – like psilocybin, MDMA, and mescaline – to study similar but novel compounds. These synthetic substances further explore the tryptamine and phenethylamine cores found in psilocybin and MDMA, aiming to develop drugs with better properties.
Compass Pathways' partnership with Jason Wallach, Ph.D., and St. Joseph’s University in Philadelphia in 2020 to create the Discovery Center serves as a perfect example. This venture has led to the creation of around 150 novel psychedelic substances intended for use in mental health treatments, many of which Compass might potentially patent and sell, similar to many other institutions with the same objectives.
Concerns over Future Regulation
The fear within the scientific community is that the classification of more compounds as schedule I could impose stringent restrictions on who can research them and how, due to the stringent rules associated with such a classification.
Federal law typically bans the government from funding research on schedule I substances and mandates registration and DEA approval to work with these substances. Under the Controlled Substances Act of 1970, a schedule I drug is defined as one having "no currently accepted medical use and a high potential for abuse".
The potential threat is that, since 2020, nearly 80 different substances have been classified as schedule I, and it does not require much evidence to attain this classification, as the January 14 rule showed.
Pushback from Psychedelic Industry
Therefore, it's not surprising that entities in the psychedelic industry are against regulations that could hinder the production and sale of psychoactive substances, the recently withdrawn DEA rule being a prime example. Notable companies, such as Tactogen and Mindstate Labs, have voiced their concerns directly and were involved in the DEA's decision to withdraw the rule. They were ready to challenge the new rule, predicting it could hamper research and development, especially for substances like DiPT.
While the DEA is known for strict regulations, this unexpected change could suggest a willingness to consider psychedelics as legitimate pharmaceuticals. Indeed, the acting DEA Administrator in 2018 stated, "We are committed to finding new and innovative ways to meet the needs of the research community".
This ongoing tension between government regulatory bodies and the pharmaceutical industry underscores the importance of better dialogue and clarification of objectives. The drug research landscape is rapidly evolving, and while there's much to be done, this event signifies a step in the right direction towards open research, access to information, and scientific advancement.
In a world where mental health is a growing concern, the potential for innovative treatments is not just exciting—it's necessary. With shifts in how institutions view substances like psychedelics, we stand on the brink of a promising horizon. It's an unpredictable journey, but like any great story, the twists and turns are what make it worth the ride.
As we continue to follow the evolution of psychedelic research, one thing is clear: change is not just on the horizon, it's here. Will we see more psychedelics make their way into the therapist's toolbox? Only time will tell.
Stay curious, stay open-minded, and stay informed. These are exciting times, and the more we learn, the better equipped we'll be to navigate the future of mental health treatments.
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FAQ: A Deeper Dive into Psychedelic Research
What are the five substances the DEA considered scheduling?
The five substances are all from the tryptamine class, and they include: 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT.
What are Schedule I-IV drugs and what do the classifications mean?
The scheduling system for drugs in the U.S. is a way to classify drugs, substances, and certain chemicals used to make drugs into five distinct categories (schedules) based on their medical use, potential for abuse, and safety or dependence potential. Here's a quick rundown:
Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and physical dependence. They are considered to have no current accepted medical use. Examples include heroin, LSD, marijuana (cannabis), ecstasy, methaqualone, and peyote.
Schedule II drugs also have a high potential for abuse which can lead to severe psychological or physical dependence, but unlike Schedule I drugs, they have accepted medical uses. Examples include Vicodin, cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), and fentanyl.
Schedule III drugs have a moderate to low potential for physical and psychological dependence, and abuse potential is less than Schedule I and II drugs but more than Schedule IV. Examples include products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, and testosterone.
Schedule IV drugs have a low potential for abuse and low risk of dependence. Examples include Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, and Tramadol.
Remember, these categories help guide law enforcement, regulation, and medical professionals, but they do not necessarily reflect the potential benefits or risks associated with any specific substance. Always consult with a healthcare professional for information related to your personal health and substance use.
Why are psychedelic substances being considered for mental health treatments?
Recent research has found that certain psychedelic substances can have profound effects on the brain and may be effective in treating various mental health conditions, including depression, PTSD, and addiction. They often work in ways that traditional treatments do not.
What is the 'breakthrough therapy designation' by the FDA?
The FDA grants a 'breakthrough therapy designation' to expedite the development and review process of a drug if preliminary clinical evidence suggests it may demonstrate substantial improvement over existing therapies for serious or life-threatening conditions.
How does the Schedule I classification affect research?
Classifying a substance as Schedule I imposes strict regulations on its use and research. Researchers must obtain approval from the DEA to conduct studies, and federal funding for such research is typically limited.
What's the potential market value for psychedelic therapies?
Current estimates project the psychedelic market value could reach over $8 billion by 2028, indicating substantial interest and potential growth in this field.
What are some key companies in the field of psychedelic research?
Companies like Compass Pathways, Tactogen, and Mindstate Labs are noteworthy players in the field of psychedelic research, actively working on developing and testing new psychedelic substances for therapeutic purposes.