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Therapies with psychedelics - Treatment of mental disorders with MDMA and psilocybin - Cannabinoids

Therapies with psychedelics - treatment of mental disorders with MDMA and psilocybin

Treatment of mental disorders - psychotherapy or medication?

In the 1950s and 1960s, new psychiatric drugs, primarily antidepressants and anti-anxiety drugs, changed the approach to treating mental disorders, relegating previously popular psychotherapy (primarily psychoanalysis) to the background. However, in the face of evidence on the highest effectiveness of treating mental disorders with a combination of pharmacotherapy and psychotherapy, this trend began to change in the second decade of the 21st century. 

The idea of incorporating fast-acting psychedelics into psychotherapy sessions is one iteration of this change. Having psychological sessions under the influence of psychedelics is called Substance-assisted therapy (SAPT) or psychedelic psychotherapy (PAP).

Medical use of psychedelics 

In recent decades, there has been increased research interest in psychedelic substances, particularly in the context of psychedelic support for the treatment of disorders such as depression (primarily drug-resistant), post-traumatic stress disorder (PTSD) and alcohol dependence.

 

Encouraging results from ongoing experiments are leading to further ones aimed at developing drugs containing psychedelics and developing specific protocols for taking the substances. The next step is to push for the development and approval of drugs containing psychedelics and the possibility for mental health professionals to legally use them in the treatment of patients with specific problems.

Under the 1971 UN Convention on Psychotropic Substances, psychedelics are among the most restrictively treated substances, both in terms of their medical and non-medical (recreational) use. This is why bringing about regulation of therapy with psychedelics is such a difficult task.

 

There are a number of international associations (operating mainly in the US, Canada and the EU) that bring together scientists, clinicians, research centers, patient associations and other types of entities that have been undertaking research, education and lobbying efforts for years to change the status quo. 

International organizations working to build knowledge and legal change on psychedelics include:

  • MAPS (Multidisciplinary Association for Psychedelic Studies),
  • APPA (American Psychedelic Practitioners Association)
  • PAREA (Psychedelic Access and Research European Alliance)

In our Polish backyard, there is a Polish Psychedelic Society, which is affiliated further afield, in larger international networks. 

Depending on the substance, the state of scientific knowledge, the advancement of experimentation and legislative action looks different. Let's look at the examples of MDMA and psilocybin.

MDMA in PTSD psychotherapy

W United States operations for the regulation of MDMA therapy have been carried out for more than 30 years. It recently completed the latest phase of clinical experiments on the use of the substance in treatment of post-traumatic stress

The data collected came from two phase 3 clinical trials, among others, which evaluated the efficacy and safety of MDMA used in combination with a psychological intervention. The effects were compared to a group that used a placebo instead of MDMA, also combined with a psychological intervention. Subjects in the study were diagnosed with severe or moderately severe PTSD.

W article published in Psychiatric Times reads that according to the researchers: 

 

"MDMA works by reducing the emotional intensity associated with traumatic memories by reconsolidating traumatic memories during psychotherapy so that they are stored with less arousal activation. It has also been noted that MDMA increases feelings of trust, safety and empathy, possibly mediated by the release of oxytocin and serotonin, which can improve the therapeutic alliance between therapist and person".

 

Already in 2017, therapy with MDMA for PTSD received Breakthrough Therapy Designation from the FDA. MDMA therapy for other indications is also currently under investigation. 

 

The Food and Drug Administration (FDA) recently approved a New Drug Application (NDA) for midomafetamine (MDMA) capsules. They are intended for use in combination with psychological intervention for people suffering from post-traumatic stress disorder (PTSD). 

 

The FDA is expected to make a decision on the application for approval of MDMA capsules as a drug to treat PTSD in August 2024. If the drug is approved, it will be the first legalized and regulated use of psychedelics in psychological therapy. 

 

Once it is approved by the U.S. Drug Administration, it will be time to translate these regulations to Europe and seek to bring MDMA capsules to our medical market.

Psylocybin in psychotherapy of drug-resistant depression

Psylocybin, a substance found naturally in mushrooms of several different species, has been studied in combination with psychotherapy in the context of various psychiatric disorders, including depression, obsessive-compulsive disorder, cluster migraine, cancer-related existential distress and anxiety disorders. The most promising data have been obtained in experiments on the treatment of patient(s) with a diagnosis of depression refractory to treatment.

Several clinical trials have shown the potential effectiveness of psilocybin-assisted psychotherapy in the treatment of patients with treatment-resistant depression, in 2018 the FDA awarded it the distinction of breakthrough therapy. 

According to the authors review published in 2023 in the journal Behavioral Sciences, The results of all studies showed a significant reduction in depressive symptoms after treatment with one or two doses of psilocybin (1 or 2 assisted psychotherapy sessions). 

Symptom improvement was immediate - in some cases, significant effects were seen as early as the first day or a week after the second dose. The improvement was long-lasting, with symptom reductions lasting up to 6, 8 and 12 months after assisted psychotherapy. 

In early 2024, a drug containing synthetic psilocybin has been approved by the FDA as an adjunct therapy for people with drug-resistant depression. 

Numerous studies are underway on the possibility of the use of psilocybin therapy in the treatment of other disorders. Studies conducted to date have included its use in The treatment of anxiety and alcohol dependence, as well as possible efficacy in the treatment of disorders obsessive-compulsive disorder and PTSD (the latter was conducted with US war veterans, among others).

Therapy sessions with psychedelics - how you conduct them matters

In the outpatient treatment of depression and PTSD, antidepressants and anti-anxiety drugs are prescribed to the patient(s) for self-administration on a daily basis, without a psychotherapeutic context.

During a psychedelic psychotherapy (PAP) session, the experiences that occur are important. In particular, these include mystical experiences, significant insights and changes in beliefs, which are often cited as factors that allow individuals to transcend their usual patterns of thinking, feeling and acting. 

During these experiences, patients/survivors may be more perceptive, exhibit deeper introspection, be less inclined to avoidance and have a sense of emotional breakthrough, all of which are helpful in building lasting change.

In publications on psychedelic psychotherapy, we read that the state of mind and attitude of those who enter the psychedelic state and the environment in which the session takes place have a major impact on the results of the therapy. 

Factors such as physical and psychological comfort, safety, the presence and attitude of the therapist, the beliefs of the person in therapy about psychedelics and mental health are emphasized. The relationship with the therapist and adequate preparation for the psychedelic session and the subsequent work with what happened during the session are important.

Applications related to treatment of depression psilocybin and PTSD using MDMA are changing the way we think about treating mental disorders. The growing body of experimental data demonstrating the efficacy of these substances underscores their tremendous therapeutic potential and small compared to other drugs side effects As well as quickly visible results. 

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