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MDMA Assisted Psychotherapy

Writer's picture: IDPATIDPAT

Alexander "Sasha" Shulgin (1925 – 2014) was an American psychopharmacologist. He is credited with introducing 3,4-methylenedioxymethamphetamine (MDMA) to psychologists in the late 1970s for psychotherapeutic use.



MDMA is a stimulant that can give feelings of energy and exhilaration. Unlike typical stimulants though, it also produces distinct social and emotional effects, and alters perception. Because of this, some scientists have proposed that it should be classed as an ‘entactogen’, meaning ‘allowing contact with that which is within’. Compared to other stimulants, MDMA is particularly powerful in releasing serotonin; boosting mood, and increasing levels of the hormone oxytocin; making users feel emotionally connected to others.

Shulgin was a highly regarded chemist. He developed the first biodegradable pesticide, a highly profitable product. He also authored a then-definitive law enforcement reference book on controlled substances, and received several awards from the Drug Enforcement Agency. In order to work with scheduled psychoactive chemicals, Shulgin obtained a DEA Schedule I license which allowed him to synthesize and possess any otherwise illicit drug. Shulgin set up a laboratory in a small building behind his house, which gave him a great deal of career autonomy. Shulgin used this freedom to synthesize and test the effects of potentially psychoactive drugs.



Shulgin reported personal revelations that "had been brought about by a fraction of a gram of a white solid, but that in no way whatsoever could it be argued that these memories had been contained within the white solid ... I understood that our entire universe is contained in the mind and the spirit. We may choose not to find access to it, we may even deny its existence, but it is indeed there inside us, and there are chemicals that can catalyze its availability."



In 1976, Shulgin introduced MDMA to Leo Zeff, a psychologist in California. Zeff used the substance in his practice in small doses as an aid to talk therapy. Zeff introduced the substance to hundreds of psychologists and lay therapists around the nation, one of these being Rick Doblin who would later go on to save MDMA research.



Unfortunately, MDMA became widely available publicly as a party drug which alarmed the authorities and lead to its scheduling as an illegal substance in 1985, and the introduction of the Anti-Drug Abuse Act the year after, which contained the Controlled Substance Analogue Enforcement Act. This law effectively put an end to Shulgin’s legal research.



The introduction of the Controlled Substances Analogue Enforcement Act at this time showed the attitude of the government: these laws made drugs illegal on the basis of their qualitative effect - not on the basis of whether they were dangerous or drugs of abuse. This legislation is thus an attempt to exercise social control, to stop people using drugs to produce altered mind states for recreational purposes, whether or not it is actually detrimental to health. It was this same attitude that lead to the sacking in 2009 of Professor David Nutt, the UK government's chief drug adviser, after he published research proving that, even in an unregulated setting, MDMA and LSD were much less dangerous than alcohol and tobacco to the user and to society.



In 1986 MAPS, the Multidisciplinary Association for Psychedelic Studies, was founded by Rick Doblin. MAPS assist scientists to design, obtain approval for, fund, conduct and report on research into psychedelics and cannabis. MAPS has funded studies on MDMA, DMT, psilocybin, ibogaine, ketamine and LSD in research centres around the world.

In 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that (1) are intended to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates substantial improvement over existing therapies. Breakthrough Therapy Designation also means that the FDA work closely with MAPS to design and conduct the research development program as efficiently as possible.

MAPS and the FDA reached agreement on the Special Protocol Assessment for Phase 3 clinical trials. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trials are acceptable to support regulatory approval by the FDA.



The most advanced psychedelic research currently is the study of MDMA assisted psychotherapy for the treatment of Post Traumatic Stress Disorder. Researchers enrolled 90 participants with severe PTSD, a condition characterized by amnesia, flashbacks, and nightmares relating to a past traumatic event, in the first phase 3, randomized, double-blind, placebo-controlled study. Participants attended an eight-hour therapy session after receiving their dose. Participants then received two MDMA-assisted therapy sessions a month apart, in addition to weekly therapy.



In follow-ups two months after their final MDMA-assisted therapy session, around two thirds of participants no longer met the diagnostic criteria for PTSD. Conversely, only one-third of participants in the placebo plus therapy condition saw a significant reduction in their PTSD symptoms. Potential negative side effects of the drug such as nausea were minimal, and there was no evidence that participants were forming addictions to the drug.



The first treatment option for people with PTSD is usually selective serotonin reuptake inhibitor (SSRI) antidepressants such as Prozac, which are usually taken on a daily basis, aren't always effective, and can come with a whole host of unpleasant side effects. Research has shown that MDMA assisted psychotherapy is more cost effective, safer, and more efficacious for PTSD than treatment with SSRI’s. There is a larger evidence base for the use of SSRI's so they will continue to be the first line treatment until more research can be carried out with MDMA assisted psychotherapy.


Researchers are currently sourcing participants for a second phase 3 trial, and if similar results are found, they believe MDMA-assisted therapy for PTSD could be approved by the FDA for clinical use by 2023.

Meanwhile, research is also being carried out, with very promising results, on MDMA assisted psychotherapy to treat anorexia nervosa and binge-eating disorder, anxiety associated with a life-threatening illness, social anxiety in autism spectrum disorders, and addiction.


MDMA must be administered by trained professionals in a controlled safe setting as part of a structured course of psychotherapy. MAPS are currently providing a clinical training program that facilitates learning in the theory, skills, and practice of MDMA-assisted therapy with the hope that their graduates will go on to practise as MDMA assisted therapists next year when it is medically legalised. Ireland currently has no plans in place for the provision of this life saving therapy. According to this study, there are a quarter of a million people in Ireland currently suffering from PTSD. Irish Doctors for Psychedelic Therapy hope to be able to work with policy makers to introduce this therapy for the care of our patients still suffering from this debilitating mental health condition.


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