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Phase I DMT Trials Show Consistent And Positive Results

DMT trials depression
Written by Sarah Friedman
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Lots of psychedelic compounds are currently under testing to assess their benefits for treating different psychological issues. Though magic mushrooms, LSD, and ketamine get the most attention, there are many more to consider. Recently, Phase I ended for Small Pharma’s DMT trials into depression, and the results so far are very promising.

Phase I DMT trials look promising which means yet another psychedelic getting closer to legalization. We’re on top of everything important in this growing industry, so sign up for The Psychedelics Weekly Newsletter to stay informed on everything happening now. You’ll also get access to exclusive & premium deals on flowers, vapes, edibles, and more! And don’t worry, our prices on cannabinoids like HHC-O, Delta 8Delta 9 THCDelta-10 THCTHCOTHCVTHCP HHC , won’t break the bank. Head over to our “Best-of” list to find your favorite products, and enjoy responsibly!


What is DMT?

N,N-Dimethyltryptamine, AKA DMT, is a psychedelic compound, meaning it fits under the category of hallucinogenic compounds, which itself is under the heading of psychoactive compounds. DMT is naturally occurring, and can be found in plants such as Psychotria viridis (one half of ayahuasca), in the bark of Virola theiodora, and in the skin of bufo toads, among other places. DMT is processed into a white powder that can be brewed into a tea, snorted, vaped or smoked, or injected.

DMT was synthesized first by Canadian chemist Richard Manske in 1931. It wasn’t found in a plant till years later in 1946 by microbiologist Oswaldo Gonçalves de Lima. It wasn’t until 10 years after that, that the hallucinogenic aspect was discovered, and this when Stephen Szara, a Hungarian chemist and psychiatrist, took DMT he extracted from the Mimosa hostilis plant.

Unlike some psychedelics like LSD and mushrooms, which provide hours long highs, DMT is a relatively short high, lasting 30-45 minutes. When it’s used in ayahuasca, in conjunction with the Banisteriopsis caapi vine, the MAO inhibitors of the Banisteriopsis caapi vine keep the DMT from breaking down as fast, which extends the high by many hours.

Phase I DMT trials

DMT is a serotonergic compound, meaning it acts on serotonin receptors, particularly the 5-ht2a receptor. At most/all receptors it acts as a non-selective agonist. Serotonin is a hormone that’s associated with mood stabilization, feeling happy, promoting well-being, but also with anxiety, and depression. Having too little serotonin is associated with depressive issues, while too much is associated with increased activity in nerve cells.

DMT has been used in history going back to around 1,000 years in the Sora River valley in southwestern Bolivia (though this is simply the earliest an artifact of this nature has been found, which doesn’t preclude its use before this time). This is known because of the finding of a pouch which contained both DMT and harmine, which together imply that ayahuasca was being made.

Many scientists believe the human body can create DMT on its own with the pineal gland in the brain. This is thought to happen when a person knows they will die, to minimize the anxiety of dying. However most research into this has been done exclusively on animals. DMT sits in Schedule I of the DEA’s Controlled Substances list, and is a Class A drug in the UK.

Phase I DMT trials

Last year I reported how the very first medical trials ever had started into DMT (called SPL026 for the study). These dose-escalating, placebo-controlled trials were conducted by Small Pharma (a neuropharmaceutical company) in conjunction with Imperial College London, and are being done to investigate DMT for the treatment of depression. Since DMT is a Class A drug in the UK, meaning completely illegal, in order to do the study, the UK Medicines and Healthcare Products Regulatory Agency had to approve the use of DMT in trials. It was announced this was approved in December 2020.

In these Phase I trials, DMT was given to a small grouping of healthy participants in order to judge safety and efficacy. In an upcoming second phase, the drug will be given to patients with depression to test its effects on depression as a part of psychedelic-assisted therapy.

According to Carol Routledge, the chief scientific and medical officer at Small Pharma, “Taking the drug before therapy is akin to shaking up a snow globe and letting the flakes settle… The psychedelic drug breaks up all of the ruminative thought processes in your brain – it literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have – and hugely increases the making of new connections.” She continues:

DMT frog

“Then the [psychotherapy] session afterwards is the letting-things-settle piece of things – it helps you to make sense of those thoughts and puts you back on the right track. We think this could be a treatment for a number of depressive disorders besides major depression, including PTSD, treatment-resistant depression, obsessive-compulsive disorder, and possibly some types of substance abuse.”

How did Phase I DMT trials turn out?

In September 2021, it was announced that Phase I of the DMT trials had come to an end, leading the way for Phase IIa trials. As explained, this second trial will use patients to start looking at the therapeutic value of the drug.

Small Pharma CEO Peter Rands had this to say about the completion of Phase I: “We are delighted to have made such swift and excellent progress in the seven months since starting Phase I.  The successful completion of Phase I means we can now truly assess SPL026 as a new potential treatment option for patients with MDD. There has been little innovation for patients suffering from MDD in the last few decades and SPL026 has the potential to change the mental health treatment landscape and provide a much-needed alternative therapy for patients.”

Dr. Routledge, explained further, “We have achieved a significant milestone in the development of SPL026. With a strong safety and tolerability profile, now demonstrated, we can move ahead with the first regulated clinical trial of DMT-assisted therapy in patients. These results lay the foundation for Small Pharma’s DMT-assisted therapy as a potential new paradigm in the treatment of MDD.”

What were the general results of Phase I? The main findings thus far, are that:

  • Individuals with no previous psychedelics experience tolerated the DMT well.
  • No statistically significant adverse events were reported, even after a three-month follow-up.
  • Though 20 adverse events were reported, they were all mild (85%) to moderate (15%), and they all resolved themselves quickly.
  • The data points to a strong correlation between the quality of the psychedelic experience and what dose was taken, with a range starting at 9mg going to 21.5mg.
  • A large data set was created that can now be used to effectively find appropriate dosing for the following phase.
  • The DMT cleared so fast from the bloodstream that it was nearly undetectable after 60 minutes, dose unrelated.
  • Psychedelic experiences lasted around 20 minutes.
ayahuasca

Since the end of Phase I in the fall, the second phase, Phase IIa, has been started with 42 patients with major depressive disorder. The main point of this phase is to judge efficacy of a 1-dose model vs a two-dose model, combined with therapy sessions for these patients. This phase also allows the company to gain further information on safety, and how well tolerated the drug is.

For the study, depression levels are measured by the Montgomery-Asberg Depression Rating scale. This will be used to assess if there is a decrease in depression after treatment. The study locations where clinical trial are being held in the UK are Hammersmith Medicines Research and MAC Clinical Research. Topline results can be expected sometime in the first half of 2022 for this part of the study.

Into the future

Though its impossible to say how a study will turn out, or whether it will produce a marketable drug, my guess is that this study will help lead to a medical legalization for DMT in some places. Though the UK is not quite as far ahead as the US in terms of psychedelics, it could be the first to pass such a legalization for DMT.

Should the US consider these study results – and assuming they are positive throughout, it’s quite likely to get a legalization there. The US is already on its way to such legalizations for other drugs. This can be seen in the FDA giving ‘breakthrough therapy’ designations to both psilocybin (twice) and MDMA, which is not only in Phase III trials by MAPS, but which had those trials planned in conjunction with the FDA to ensure results meet regulation.

On a state level, there are tons of locations now that have decriminalized magic mushrooms and/or entheogenic plants as a whole, like Detroit, Seattle, Denver, and the state of Oregon, which also legalized them for medical use. Three states are also attempting to push through state-wide recreational legalization measure. Though the laws are slightly different by location, California, Michigan, and Washington are working to get initiatives through.

Conclusion

We’ve still got plenty of time until final results come in on this study, but the Phase I DMT trials sure show a lot of promise. With psychedelics becoming more accepted, and getting closer to large scale legalizations, its certainly not out there to think that DMT could be one of the first to get a pass.

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DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

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About the author

Sarah Friedman

I am a US born writer, travelling the world and doing the digital nomad thing.

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