DEA’s increased DMT quota signals positive advancement in psychedelic research

The Drug Enforcement Administration has raised the 2025 legal production quota for the psychedelic Dimethyltryptamine from 11,000 grams to 20,000 grams, saying it agrees with requests for the adjustment to “support legitimate research and scientific efforts” to develop a Food and Drug Administration-approved drug based on Dimethyltryptamine.

The Drug Enforcement Administration’s (DEA’s) acknowledgment that more Dimethyltryptamine (DMT) is needed for research is a good sign for the development of psychedelic therapies. Early clinical evidence suggests DMT psychedelic-assisted therapies could potentially treat mental health disorders, such as major depression and brain injuries resulting from strokes.  

DMT is a naturally occurring compound found in various plants and animals, and it is known for its mind-altering properties. It’s the main psychoactive ingredient found in ayahuasca—a ceremonial tea—and has been historically used by indigenous cultures for religious ritual and therapeutic purposes. Today, synthetic DMT is produced in labs, and while many associate it with recreational use and its powerful, short-lived “breakthrough” experiences, emerging research suggests its potential as a medicinal drug.

One of the main concerns surrounding DMT is its safety, but recent research may ease some fears.  A 2022 London clinical trial investigating DMT-assisted therapy for Major Depressive Disorder (MDD) revealed no serious drug-related adverse events, concluding that DMT-assisted therapy has a favorable safety and tolerability profile in proper clinical settings. All of the reported side effects were minimal and short-lived. Of 20 drug-related adverse events, all were mild (85%) or moderate (15%) and resolved rapidly and independently. Moreover, there were no significant negative effects on anxiety and well-being reported at any point during the three-month follow-up. None of the participants expressed any regrets, and most of them reported their experience as pleasurable and not too challenging.

In Canada, where the government can more easily allow companies to research uses of controlled substances than in the United States, DMT-assisted therapy research has shown promising preliminary evidence for treating brain injuries resulting from strokes. Algernon Pharmaceuticals Inc., a Canadian clinical-stage pharmaceutical development company, recently announced its plans to advance with its DMT stroke research program as its lead asset.

Christopher J. Moreau, CEO of Algernon, stated, “Investigating neuroplasticity in a clinical setting, as a potential new treatment approach for … stroke patients, is a new and promising area of research.” The company decided to advance into a Phase 2 study based on positive data from their Phase 1 trial. Phase 1 results demonstrated that a six-hour DMT infusion could achieve levels linked to neuroplasticity (the brain’s ability to change and adapt) in preclinical studies without causing a psychedelic experience.

In some countries, including England and Canada, early research suggests DMT-assisted treatments have therapeutic value and favorable safety profiles, permitting further investigation into DMT’s pharmaceutical potential. However, in the U.S., research on psychedelic drugs, such as DMT, is hindered by their classification as Schedule I substances under the federal Controlled Substances Act—drugs deemed by the government to have no currently accepted medical use and a high potential for abuse. 

Any drug seeking approval must first present significant clinical evidence showing that it meets FDA safety and efficacy standards. However, Schedule I drugs face significant barriers to research and development, making it much more difficult for them to demonstrate what the FDA demands. The FDA deems DMT and other psychedelics as inherently “dangerous,” and federal law prohibits the manufacture, distribution, dispensation, and possession of Schedule I substances except for federal government-approved research studies. This criminal status under federal law has a chilling effect on companies and investors who might otherwise be willing to deploy resources into further research. As a result, private investment in the development of these drugs is limited, and psychedelics researchers often find themselves pleading for public funding.

The DEA’s recognition that more DMT is needed for research is a huge step towards its advancement. It signals the growing federal realization that psychedelic therapies may hold promise in the treatment of several health conditions and that the barriers to the development of these treatments could be removed in the future.

The FDA, under the Trump administration or another future administration, might choose to rely on real-world evidence, such as the recent pre-clinical evidence from England and Canada, as a basis for granting “breakthrough therapy” designations for psychedelic-assisted treatments, potentially accelerating the development and review of these treatments.

Several foreign governments have already reframed drug regulatory frameworks to expand psychedelic research. The DEA now acknowledges that more DMT is needed for research. If more breakthrough designations are issued to psychedelics like DMT, Americans suffering from debilitating conditions might gain access to these treatments in the future.

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