Ecstasy, LSD, and some hallucinogenic mushrooms are for the most part recreational drugs, but more than half a century ago they were studied for their promising uses in medicine: the change in consciousness and neuronal plasticity they generate make them candidates for treating trauma or depression. severe. The investigations were put on hold due to the US government’s war on narcotics in the 1970s. Until a few years ago, when rehearsals were resumed. Since 2020 there has been a medication on the market to treat depression – based on ketamine – and two others appear to be on the market very soon. The European Medicines Agency (EMA) is already preparing for its use and in recent weeks has held meetings with experts in the field to articulate the deployment of these new therapies.
Because these types of substances, if approved, will not be like conventional treatments. Antón Gómez-Escolar, psychopharmacologist, popularizer at @drogopedia and author of the Essential Guide to the Psychedelic Revival, explains that it will not be a pill that the doctor prescribes and the patient can buy it at the pharmacy to take it at home: “Due to its characteristics, it will most likely be for exclusively hospital use, under the supervision of specialists, and will be taken that must be complemented with specific psychotherapy.” It is the way in which they are demonstrating their positive effects: some trials are managing to be effective in just a few sessions for serious mental health problems that had not responded to other drugs.
The expert explains how these drugs work: “On the one hand, due to neuroplasticity; The brain becomes much more capable of changing, in a psychotherapy context, it allows this work to be much more effective and lasting. It is not necessary to spend months of treatment. There are people who describe that one session is equivalent to years of therapy, in a single afternoon. Because [las sustancias] They give access to parts of the psyche that are not accessible, or that would require a lot of work to reach. On the other hand, the substances themselves trigger a series of subjective experiences that usually have many contents of great value for psychotherapeutic work. “You can get the person to realize certain things that would be very difficult without them.”
While it lasts journey of the patient, must be accompanied by specialists (at least one), who must also be alert in case any adverse effects arise. He high It depends on the active ingredient. With 5-MeO-DMT – a psychedelic substance secreted naturally by the Bufo Alvarius toad that is tested for various disorders – it is a matter of 10 or 20 minutes, but in the case of MDMA – also known as ecstasy – and psilocybin ―present in certain types of mushrooms, sometimes referred to in the recreational drug market as magic mushrooms― can be up to six or seven hours.
Before administration there is a preparation, in which the patient is made aware of what he is going to experience, and psychotherapy, which can be carried out during the effects of the substance (in the case of MDMA and psilocybin) or afterwards (as happens with 5-MeO-DMT). In it, the patient’s problems are investigated, in a similar way to normal therapy, but with the advantage that the brain is in conditions that may be more conducive to developing changes. This allows you to see results in very few sessions, even from one.
Gómez-Escolar is one of the experts who participated in a workshop with the EMA in April, the first to be held on these substances for medicinal purposes. His medical director, Steffen Thirstrup, said earlier this month in a virtual meeting that it is “time to give a second chance” to psychedelic substances for mental disorders. “If we look back, in the last decade we have not seen any therapeutic advances for these disorders,” he stated.
The treatment that seems closest on the market is MDMA-based. The public benefit company Lycos (which began as an NGO, called MAPS) has already completed clinical trials with very positive results: two-thirds of symptoms resolved in post-traumatic stress patients who had failed other treatments. The documentation for its approval is in the hands of the US regulatory agency (FDA).
For most medicines, this is usually the first step before the same process passes through the EMA and reaches member countries. Although it is impossible to specify when they will be in the system, experts believe that this year it is very possible that it will be approved in the United States and, a few months later, in Europe.
Óscar Álvarez Bobo, a psychiatrist at the Parc Sanitari Sant Joan de Deu who has participated in several trials with psychedelics (such as the one mentioned above), believes that they are very close to reaching the market. “If everything goes well, which remains to be seen, because making such innovative and controversial drugs, there is a lot of scrutiny by regulatory entities to see that they work and there are no dangers,” he clarifies.
The next drug that could hit the market soon has psilocybin, which is found in mushrooms, as its active ingredient. Álvarez Bobo is leading one of these studies, already in phase 3 (the last one before commercialization). “It gave us quite promising results, with rapid and lasting improvements in patients with resistant depression, that is, who had not responded to other medications, and without signs that the treatment incurs much risk,” says the researcher, who believes that in About a year it could be available.
The only country that is already using both MDMA and psilocybin is Australia, where it is done under highly taxed conditions, something similar to what in Europe is called “compassionate use”, the use of very advanced but not yet approved drugs when there are no alternatives. .
In addition to those mentioned, other substances and indications are being studied, but their arrival in therapeutics does not seem as imminent as the previous two. Some examples are LSD for anxiety, or 5-MeO-DMT for various disorders, such as major depression, anxiety, post-traumatic stress disorder. Besides, The European Union is financed with more than six million euros research into the use of hallucinogenic substances for palliative care, another field where researchers believe it can help patients cope with death.
The adverse reactions seen in most trials are mild: sometimes nausea, dizziness or headache occur, which usually resolve on the same day or the next. Some people treated with these drugs have also reported more serious effects, such as suicidal ideation. But since these types of behaviors are much more likely to occur in patients with serious mental disorders, it is not at all clear that they are an adverse effect of the medication itself.
Difficulty applying treatment
The first medications that will reach the market will not, in principle, be first choice. That is, they will be used when the most common ones have failed. In fact, most of the trials are being done with patients who “have been using other methods for years and are not getting out of the hole,” in the words of Gómez-Escolar.
This is so for several reasons. As Álvarez Bobo acknowledges, it will not be easy to apply them. The fact that they are banned substances already makes it very difficult to experiment with them, and only doctors who are involved in clinical trials have the knowledge and experience to handle them. “One of the big problems we will encounter will be how to apply the treatments, how to scale them to ensure that they reach the maximum number of people possible. Psychologists and psychiatrists have no experience. Both in Sant Joan de Deu and in the Spanish Society of Psychedelic Medicine (SEMPsi) [de la que es miembro] We are working to do training and certifications,” he points out.
The public system will be faced with a challenge when it has to integrate them into the system, since they are very disruptive compared to almost any conventional treatment. That is why it is also very difficult to establish how many people they will benefit or what their cost will be. That is precisely what the EMA is now exploring with the help of experts in the field.
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