Opinion – Psychedelic Turn: Clinical trials and legalization advance in 2022; companies retreat

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Opinion – Psychedelic Turn: Clinical trials and legalization advance in 2022;  companies retreat

The year 2022 ends with some good news in the psychedelic field, others not so much. As far as research and regulation are concerned, things have moved further, as investor excitement over the therapeutic market for mind-altering drugs has waned.

There were three days left to end the year in which Brazil got rid of Jair Bolsonaro as president when another clinical test came out showing the antidepressant effects of psilocybin from “magic” mushrooms. Held in Switzerland, it brings some news about the previous ones.

The team led by Franz Vollenweider, a well-known psychedelic researcher, used a single moderate dose of psilocybin, around 15 milligrams (versus the usual two doses of 20-25 mg in other studies). 52 people participated, 26 of them in the placebo control group.

Vollenweider’s article appeared in the open access journal eClinical Medicine, from the Lancet group. Followed for two weeks, volunteers diagnosed with depression showed a significant reduction in the severity of symptoms. In the group that received the psychedelic, 14 of 26 of them (54%) were in remission.

Although lower, the dose used still caused considerable change in consciousness. However, the improvement in symptoms did not correlate with the intensity of the subjective experience, as other research suggested – scientific debate thus continues about the psychedelic “trip” being necessary for therapeutic benefit.

Although one of the first placebo-controlled clinical trials, the study was neither the only nor the largest. Less than two months earlier, the company Compass Pathways had published in the New England Journal of Medicine the results of its multicenter (ten countries) phase 2 trial of 233 patients with treatment-resistant depression. In this case, 29% of the volunteers who took 25 mg of psilocybin were in remission after three weeks.

Even more advanced is the clinical trial of MDMA, the active ingredient in the recreational drug ecstasy (also known at night as bullet, molly, Michael Douglas), against post-traumatic stress disorder. The Multidisciplinary Association for Psychedelic Studies (MAPS) has completed the second major Phase 3 MDMA study.

It is expected that these results will lead to the approval, by the US agency FDA, of drug-assisted psychotherapy, more appropriately qualified as “empathogenic” (it is not a classic psychedelic, such as mescaline, LSD, psilocybin or DMT, of ayahuasca). This license could occur in 2023 or 2024.

Off the rails of medicalization, the greatest advance took place with psilocybin from fungi psilocybe cubensis. Its in natura use in adults had already been approved in 2020 by voters in the US state of Oregon, legalization that comes into full force next month; in November, the psychedelic mushroom regulation was enshrined in Colorado ballots.

Despite the favorable wind, the psychedelic wave ebbed on the investment fringe. The company Compass Pathways is well established, having raised US$ 225 million in the market in 2021, but in 2022 a movement of mergers and acquisitions began, indicating that some of the startups surfing on the initial enthusiasm had unsustainable business plans and that the money waned.

The economic insecurity triggered by the war in Ukraine and the pandemic will have contributed to reduce investor enthusiasm. This although they have also favored the increase in anxiety and depression rates, therefore the demand for alternatives to ineffective off-the-shelf drugs for most of those affected by mental disorders.

It is not ruled out, moreover, that the avalanche of patent applications will begin to encounter greater resistance. Whether from intellectual property agencies, due to the lack of innovation in the use of psychedelic substances used for generations and generations, or due to the lack of clear and credible plans for sharing benefits with traditional peoples who bequeathed them to biomedical science, as mandated by the Protocol from Nagoya.

This ebb seems natural. As common sense says, when the tide is low you can see who was swimming naked.

To learn more about the history and new developments of science in this area, including in Brazil, look for my book “Psiconautas – Viagens com a Ciência Psychedelica Brasileira”.

Be sure to also see the reports from the series “A Ressurreição da Jurema”:

https://www1.folha.uol.com.br/ilustrissima/2022/07/reporter-conta-experiencia-de-inalar-dmt-psicodelico-em-teste-contra-depressao.shtml

https://www1.folha.uol.com.br/ilustrissima/2022/07/da-caatinga-ao-laboratorio-cientistas-investigam-efeito-antidepressão-de-psicodelico.shtml

https://www1.folha.uol.com.br/ilustrissima/2022/07/cultos-com-alucinogeno-da-jurema-florescem-no-nordeste.shtml

It should be remembered that psychedelics are still experimental therapies and certainly do not constitute a panacea for all psychic disorders, nor should they be the object of self-medication. Speak with your therapist or doctor before venturing into the area.

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