Breakthrough in psychotherapy

Therapy using MDMA was given the status of "breakthrough"

Julia Korowski, XX2 century, based on MAPS: FDA Grants Breakthrough Therapy Design for MDMA-Assisted Psychotherapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials

The US Food and Drug Administration (FDA) has assigned the status of "breakthrough therapy" to psychotherapy using MDMA. This means that the substance has proven itself well during preliminary clinical studies, in this case as a drug for the treatment of post—traumatic stress disorder (PTSD). The new status will speed up the process of developing and approving this type of therapy. However, in order to evaluate the effectiveness of MDMA, scientists will have to conduct phase III trials.

The term "breakthrough therapy" sounds loud, but in practice it means that:

• the medicine is intended for the treatment of a serious or life-threatening disease;

• preliminary studies have shown that the drug may be more effective than existing treatments for one or more indicators.

Substances that have been assigned this status must go through all phases of clinical trials, but the FDA is trying to speed up the process. In addition, such drugs pass the approval stage faster. MDMA is known to ordinary people, first of all, as a drug, and the drug owes its rehabilitation in the eyes of the public to an organization called the Interdisciplinary Association for Psychedelic Studies (MAPS).

Rick Doblin founded MAPS in 1986. He was convinced that psychoactive substances could be used for medicinal purposes. MAPS actively studied PTSD psychotherapy using MDM — the organization not only raised money for research, but also conducted its own experiments. In 2011, scientists published the results of a pilot clinical trial, followed by experiments on larger samples — this time, scientists not only from America, but also from Israel and Canada. 107 people took part in the trials of the second phase — they underwent several psychotherapy sessions, and during three of them they took MDMA. After 12 months, the experimenters assessed the condition of 90 subjects and found out that 68% of PTSD is no longer diagnosed. At the same time, at the beginning of the study, these people suffered from the disease, on average, 17.8 years.

These (as yet unpublished) results impressed the FDA, and the Administration not only assigned the substance a special status, but also agreed to conduct two phase I clinical trials. One of them will begin next year, and a total of 200 to 300 people will take part in the experiments. It will take about $25 million to complete the research, but so far MAPS has collected only half of this money. According to Doblin, scientists will start clinical trials anyway. "MAPS has always had this philosophy: if we can work, money will appear," he says.

Post-traumatic stress disorder ("Afghan syndrome", "Vietnam syndrome", etc.) is a severe mental condition that occurs as a result of traumatic situations, for example, participation in hostilities, physical trauma, sexual violence, etc. The course of PTSD is manifested by repetitive and obsessive reproduction of a traumatic event in consciousness. At the same time, the patient experiences severe stress. PTSD is also characterized by recurring nightmares and involuntary memories.

Portal "Eternal youth" http://vechnayamolodost.ru  05.09.2017