Despite the recent discoveries of the therapeutic potential of psychedelics for human welfare, the Drug Enforcement Agency announced that it would be adding five variants of these drugs to the harshest drug classification—Schedule 1. This recent move will discourage the growing support for psychedelic research in the country.
A few months ago, some state legislatures decided to permit research on psychedelic drugs, only for the DEA to announce its move to reclassify some of these drugs into its most restrictive category for controlled substances. Scheduling one class consists of drugs claimed to have the highest potential for addiction with very little medical value. Scientists are prohibited from conducting research on most of the drugs in this category, which is one of the reasons why cannabis legislation has dragged on for so long.
The five psychedelic drugs to be included in this category include 5-Methoxy-alpha methyltryptamine (5-MeO-AMT), N, N-Diisopropyltryptamine(DiPT), N-Isopropyl-5-Methoxy-N-Methyltryptamine (5-MeO-MiPT), 4-Hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT), and N, N-Diethyl-5-methoxytryptamine (5-MeO-DET).
Psychedelic Research in Recent Years
Tryptamine or psychedelic drugs such as psilocybin have been scientifically investigated in recent months. The findings from these studies suggest that the drug could be a potential treatment or therapy for managing mental disorders, especially severe depression in adults. The information on these drugs is limited due to the excessive restrictions on their research.
In 2021, the Food and Drug Administration admitted that psilocybin therapies have medical values. Many expected this confirmation to be followed by a relaxation of current restrictions on the drug for further investigation. Instead, the DEA has followed up with a move that is more or less puzzling to everyone.
The DEA's Move
The Drug Enforcement Agency announced its proposal in a published document in the Federal Register. The agency says that a 2012 study done by the Health and Human Services Department on the relationship between hospital emergency room admissions and 5-Meo-AMT and 5-MeO-MiPT abuse discovered that the tryptamine drugs played a role in the deaths of the admitted patients. According to the study, a patient who died in the emergency room had their cause of death be due to abuse of 5-MeO-AMT. The deceased was reported to have taken the drug with the antidepressant bupropion and alcohol. The doctors in charge could not clarify the role the psychedelics played in the death.
What the DEA has just done is to obstruct the scientific investigation of these five substances effectively. The drugs will be prohibited for use, sale, and production. And all research into the related compounds will be banned. Scientists are concerned that this proposal will affect not only the five tryptamines but also other psychedelics in circulation. It could also provide lawmakers with enough reason to halt ongoing research on major psychoactive compounds.
License to Research
Tactogen CEO Matthew Baggot described the move as "outrageous" to scientists based in institutions across the country. The co-founder of the pharmatech startup explained that the five compounds listed in the proposal are currently bound by the Federal Analogue Act; this law prohibits consumers from ingesting the drug but leaves a grey area open for possession. The DEA's proposal would not only prohibit the use of the drug it would also criminalize its possession. Researchers can research these compounds because they are legal to possess, but that seems to be ending soon. Once the new proposal is approved, scientists like Baggot will need to procure a permit from the Drug Enforcement Agency to possess the compounds for research purposes.
Neuroscientist Baggott and his team at Tactogen are working to produce the next level of MDMA-like medicines with fewer addicting impacts. He stated that the inclusion of these compounds into the Schedule 1 category would severely limit researchers. According to the existing provisions on Schedule 1 drugs, the compounds and all structurally related compounds that are positional isomers will be affected. This means that hundreds of potentially useful drugs will not be studied. The Tactogen CEO explained further that a compound's positional isomers could effectively entangle at least one hundred chemically adjacent compounds.
Matthew Baggott pointed out that his team's work would be affected by the proposal because they use one of the listed compounds on their current project. The tryptamine, 5-MeO-MiPT, is used as a comparison compound in his lab. He clarified by saying, "When a new compound is synthesized, it must first be compared with a compound with known effects." He added that tryptamine is a scientifically exciting drug due to the unique psychedelic effects observed at higher doses. At low doses, the drug has MDMA-like effects.
This proposal could potentially undo the progress made by the Tactogen team. Their objective to develop a more sustainable variant of MDMA compounds will be slowed down until they can procure licenses from the agency to carry on. Baggott stressed that the 5-MeO-MIPT offers valuable clues to the project. There is a high chance that other studies across the country need one or more of these listed compounds to proceed.
Available reports suggest that obtaining permits for research for the DEA is a very complex process. Baggott supported the claims, stating that whenever a drug is added to Schedule 1, teams go through onerous hoops to get licensed for research. It's especially more difficult when the unit is trying to attain licensing for multiple projects.
Conclusion
The approval of this proposed move could terminate many ongoing studies on tryptamine drugs. Not all researchers will be willing to go through the stress of obtaining multiple permits to study these compounds in various institutions or laboratories. For instance, recent biotech projects are collaborations between modern biotech companies, with each member organization running specialized analyses at their research locations. The proposed move could mean that each member has to apply for individual permits to study any listed drugs and their positional isomers. From experience, many research sites would instead begin afresh with a different compound than go through the bureaucratic hurdles for small projects.
Startups like Tactogen could even lose collaborators due to this, resulting in a lag time that could potentially destroy available research. No one would blame these budding startups if they chose to stop investigating the possibilities.
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