The Brain Institute of the Federal University of Rio Grande do Norte has started clinical trials with vaporization of the psychedelic dimethyltryptamine (DMT) – a psychoactive component of ayahuasca – for treatment-resistant depression. Canadian company Biomind Labs, partner of ICe-UFRN, announced the first inhalation of DMT in the pilot stage of a phase 1/2 clinical trial.
The group of physicist Dráulio Barros de Araújo at UFRN thus continues its pioneering study with ayahuasca, the first to test a psychedelic substance for depression following the gold standard of biomedical research (double-blind placebo-controlled trial). At the time, it was proved that the tea had a rapid and sustained antidepressant effect for seven days.
The scientific article came out in 2018. This and other studies with ayahuasca, such as those at USP in Ribeirão Preto, put Brazil in third place in the world in impact studies on psychedelics..
The difference is that, this time, the drink from religions such as Santo Daime, UDV and Barquinha was not used, but pure DMT. In the form of a drink, ayahuasca needs to be prepared with plants containing beta-carbolines, such as cipó-mariri, as these substances inhibit the degradation of DMT from the chacrona bush in the digestive system.
The experiment uses the Volcano Medic vaporizer, already used for cannabis compounds. Through the airways, DMT enters the bloodstream and reaches the brain faster.
The effect lasts 10-15 minutes, an interval much more compatible with clinical application than the three hours or more of ayahuasca. Araújo will also test intramuscular injections of DMT, whose effect lasts for about an hour.
One of the objectives is to compare the two forms of administration of DMT and measure the antidepressant effect of each one. The physicist also hopes to glean some clue as to the contribution of the psychedelic experience itself (the “trip”) to the therapeutic benefit under investigation.
Not everyone is willing or prepared to face the extended journey. In this case, inhalation may be a better option for the depressed person (there is already a dissociative substance against depression for use via the nasal route, esketamine).).
On the other hand, many researchers believe that the psychedelic experience is important, if not essential, for the healing process. This is because it brings out repressed mental contents, such as traumas, which serve as raw material for psychotherapy.
In the plan of Dráulio Araújo, 50, is to investigate DMT in an integrated way, “from A to Z”. He is finishing up the crew at UFRN, with about 20 people, including psychiatrists, psychologists, chemists, nurses, animal experimenters and physiologists.
“I’m having fun like never before doing science,” celebrates the physicist and head of the team, which will begin recruiting patients in the coming weeks. He is committed to Biomind to complete the inhalation trial by the end of this year.
The partnership started about a year ago. The Uruguayan Alejandro Antalich, founder of Biomind, had sold Aurora Cannabis the first company to produce marijuana for a national government, ICC Labs, and wanted to apply his experience with the regulation of controlled substances to the effervescent branch of psychedelics.
He searched for a researcher for three months, until he attended a lecture by the Brazilian. For Antalich, 49, in addition to his experience with ayahuasca and depression, Araújo was the perfect fit for his plans with Biomind:
“Someone who would align with one of my main goals, democratic access to new drugs capable of offering a second chance to millions of patients who have lost all hope with existing treatments and drugs.”
Brazil should be one of the pioneer countries in validating and recognizing the value of scientific research around different psychedelic substances in recent years, he argues: “Just thinking that several plants native to Brazil produce these psychedelic active principles should be more than enough reason to promote psychedelic science and legislate accordingly.”
According to the Uruguayan, 1 billion people, one-eighth of the world’s population, face some type of mental health disorder, for which no treatment innovations have emerged in the last five decades. “Unfortunately, we lost more than valuable investigation time, because psychedelic substances were included in list 1 [Schedule 1, rol de drogas proibidas capitaneado pelos EUA].”
He cites a phrase he heard from Araújo as soon as the Brazilian signed the partnership: “There is an unknown island in the ocean of new drugs [nos] waiting. I [Araújo] I have the map, and Biomind Labs, the boat to navigate the turbulent waters and reach the island.”
There would be three pillars of the strategy pursued by the company: emphasis on patients, research and accessibility. In other words, employing science to develop formulations and application pathways to expand the number of underserved people who can benefit from psychedelics.
Biomind follows the conventional path of drug development, with clinical trials designed to meet the criteria required by regulatory agencies such as the FDA and Anvisa.
This requires a lot of investment, which the company will seek from the Canadian capital markets, where it is listed on the Toronto Stock Exchange. This allows you to raise funds in the United States as well. The company has just installed an operations center on the University of Cambridge Biomedical Campus, UK.
Intellectual property, according to Antalich, is another important part of this strategy. Biomind has already filed 20 patent applications in 15 months (including mescaline and 5-MeO-DMT).
But he sees no risk of the applications being questioned because they deal with substances in traditional use. This is what has been happening with companies like Compass Pathways, which has advanced clinical trials with psilocybin for depression, which is now under dispute.
“Our strategy goes in totally opposite directions, in which what is really protected are innovative formulations and drug delivery systems”, he explains, and not the substance itself (DMT, by the way, is endogenous in the human brain). “We do not protect molecules or new chemical entities developed by modifying psychedelic parent molecules.”
The stated objective is to universalize use regardless of patient income. Hence the need to better fit psychedelic treatment into clinical practice, without making it more expensive with hours and hours of specialized monitoring throughout the duration of the trip.
“In line with our main goal, accessibility, we focused on shortening the session time required for the psychedelic experience. The longer it is, the less accessible the treatment is.”
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To learn more about the history and new developments of science in this area, including in Brazil, look for my book “Psiconautas – Travels with Brazilian Psychedelic Science”
Chad-98Weaver, a distinguished author at NewsBulletin247, excels in the craft of article writing. With a keen eye for detail and a penchant for storytelling, Chad delivers informative and engaging content that resonates with readers across various subjects. His contributions are a testament to his dedication and expertise in the field of journalism.
