01 December 2016

"Ecstasy" by prescription?

Large-scale clinical trials of ecstasy have been allowed in the USA

Oleg Lischuk, N+1

The U.S. Food and Drug Administration (FDA) has approved large-scale clinical trials of methylenedioxymethamphetamine (MDMA, MDMA, "ecstasy"). A potential indication for its use was post-traumatic stress disorder (PTSD), writes The New York Times (F.D.A. Agrees to New Trials for Ecstasy as Relief for PTSD Patients).

MDMA is a psychoactive substance acting on serotonin, dopamine and norepinephrine receptors of the brain, which various authors classify as a psychostimulant, euphoretic or empathogen-entactogen. Due to its ability to give a positive color to the perception of the world, people and events, it was repeatedly and often successfully used in experimental psychotherapy in the 1970s. After the inclusion of MDMA, along with most well-known psychedelics, in the lists of controlled narcotic substances in most countries of the world, such studies practically ceased. However, in recent years, by the efforts of expert initiative groups, interest in the potential medical use of these substances has begun to resume. One of the areas of their experimental application has become PTSD – a severe psychological condition resulting from various traumatic experiences associated with violence and suffering, such as, for example, military operations, natural disasters, terrorist attacks and others.

Based on the positive results of several previous small studies, the FDA approved the conduct of phase III clinical trials (it examines the effectiveness and safety of verified doses of the drug, which results in a conclusion on the feasibility of clinical use). At least 230 patients with PTSD who have not been helped by other types of treatment will take part in them. Volunteers will be given psychotherapy in combination with MDMA sessions in comfortable conditions under the supervision of specialists.

In one previous study, 12 weeks of psychotherapy and three eight-hour sessions with MDMA, in which participants shared their traumatic memories with psychologists, led to a reduction in PTSD symptoms by an average of 56 percent, and the effect persisted for at least a year.

The Interdisciplinary Association for Psychedelic Research (MAPS), which advocates the medical use of marijuana, MDMA, LSD, psilocybin and other controlled psychoactive drugs, is the sponsor of the conducted and future trials.

The organizers of the trials have applied for the assignment of MDMA-psychotherapy status of "breakthrough therapy", which, if the study is successful, will ensure the accelerated introduction of this type of treatment into clinical practice. In this case, we are already talking about 2021.

Earlier, British researchers confirmed the effectiveness of psilocybin – the active substance of hallucinogenic mushrooms of the genus Psilocybe in severe depression. This and similar work was carried out by the staff of the Center for Neuropsychopharmacology at Imperial College London, which is similar in purpose to MAPS. It was established by the well-known neuropharmacologist and psychiatrist David Nutt (David John Nutt) after being dismissed from the post of head of the Advisory Council on Combating Drug Abuse at the British Interior Ministry (ACMD) for public statements about the exaggerated danger of a number of prohibited substances.

RelativeDrugHarms.png
Graph from Nutt et al. Drug harms in the UK: a multicriteria decision analysis
(The Lancet, 2010) – VM.

Portal "Eternal youth" http://vechnayamolodost.ru  01.12.2016


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