"Psychedelics have already proven to be effective in alleviating anxiety and existential distress in oncology patients with terminal diagnoses. However, they also show great promise in other diagnoses, particularly depressive disorders or addictions. At NUDZ, our teams have been researching psychedelics for about 20 years, including studies in patients, both in the indication of depression and within palliative care. The workshop addressed the question of psychedelic regulation and approval for therapeutic use," explains Dr. Tomáš Páleníček from the National Institute of Mental Health.

Placebo from psychedelics in a blinded study

The workshop was attended by a wide range of experts from the European area, including the United Kingdom, as well as from Canada, the United States, and Australia, where programs already exist. The last three states already allow the use of certain psychedelics (specifically psilocybin and MDMA) in the treatment of patients with selected mental disorders or within specific treatment programs. "The event was attended by world experts, representatives of the academic community, representatives of pharmaceutical companies conducting clinical evaluations with psychedelics, representatives of patient organizations, psychiatric societies, the European Monitoring Center for Drugs and Drug Addiction, and, most importantly, representatives of EMA as the regulatory body that approves or registers drugs for human use within Europe," explains Dr. Páleníček.

For the Czech Republic, two representatives were present: Professor Jiří Horáček and Dr. Tomáš Páleníček from the National Institute of Mental Health and the 3rd Faculty of Medicine, Charles University. Issues related to authorities' access to controlled clinical studies, which have their specific features in the case of psychedelics, were discussed. "For example, the issue of blinding with a placebo is problematic. Simply put, in blinded studies, the participant does not have the opportunity to distinguish whether they were given a placebo or the tested substance. However, with psychedelics, this is not entirely possible due to their recognized psychoactive effects. The second key aspect is that psychedelics are typically administered under the supervision of therapists/doctors, and typically involve treatment with psychological support or even talk of psychedelic-assisted psychotherapy. This naturally creates a certain dilemma as to whether the psychedelic is effective on its own or only in tandem with psychological or therapeutic support. However, the current concept of approving drugs for psychiatry does not consider the synergistic effect of these two principles. Additionally, the need for psychotherapy or psychological support raises further questions related to treatment costs, which may be increased by this need. It is then a question of how much treatment actually costs, for example, treatment in hospitals versus several therapeutic sessions with the substance and any difference in the speed of normalizing the work efficiency of patients, which may support their use due to the rapid effect of psychedelics," explains Dr. Páleníček. Issues related to the administration of psychedelics to underage patients within therapeutic practice were also discussed.

Preparation for integration into care

"One of the key positions is that it will be necessary to adapt some of the evaluation methods used in clinical studies so that the risk/benefit ratio of psychedelic substances in the therapeutic indication can be objectively assessed. The EMA is preparing for psychedelics to likely be integrated as a therapeutic alternative into mental health care. In this context, it will also be necessary to evaluate the cost-effectiveness of this type of treatment and its integration into the system and reimbursement within insurance. The impact on the Czech Republic will be such that if psychedelics are approved by the EMA for clinical use in the EU, they will most likely subsequently be available as an alternative for treatment in the Czech Republic. It is very likely that if this happens, the concept of treating certain mental disorders may fundamentally change," concludes Dr. Páleníček.

The Czech Republic is among the pioneering countries in the EU where studies with psychedelics are already underway. A number of studies are being conducted at the National Institute of Mental Health, investigating, for example, the potential use of psychedelics in the treatment of resistant depression or in palliative care. Czech research would not be possible without the contribution of state grant agencies, specifically the Agency for Healthcare Research (AZV) under the Ministry of Health of the Czech Republic (formerly the internal grant agency of the Ministry of Health), operational programs under the Ministry of Education, Youth and Sports co-financed by the EU, and without significant philanthropic support through charitable funds such as PSYRES or Abakus, which in the past year accounted for approximately 30% of the support for psychedelic research in the Czech Republic. Most recently, the NUDZ team succeeded in obtaining the prestigious international European project PsyPal for the use of psilocybin in palliative care from the Horizon Europe call. Non-profit associations such as PsychedelicsEUROPE, initiated by Czechs, which were also present at the workshop, help communicate the regulation of psychedelics and their implementation into mental health care at the European level. Czech experts' experiences can thus play a key role in shaping European regulations for clinical use of psychedelics. Psilocybin is currently closest to submitting a registration application. Other hot candidates include DMT, 5-MeO-DMT, LSD, and MDMA.

 

 

 

 

 

 

 

 

 

 

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